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From: TSS ()
Subject: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) {TSEs} Guidance for Industry
Date: February 27, 2007 at 2:11 pm PST

Guidance for Industry

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Additional copies of this draft guidance are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at http://www.fda.gov/cber/guidelines.htm.

For questions on the content of this guidance, contact the Division of Human Tissues, Office of Cellular, Tissue and Gene Therapies at 301-827-2002.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Biologics Evaluation and Research

February 2007

snip...

This guidance finalizes the draft guidance, "Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated May 2004," (Ref. 3). This guidance also finalizes the draft guidance, "Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)," dated June 2002 (Ref. 4).

snip...

C. How do I assess a donor of dura mater for TSE?
You must perform an adequate assessment for donors of dura mater to detect evidence of TSE (§ 1271.85(e)). After the dura mater has been removed, you should have a qualified pathologist perform an examination of the donor’s brain. Following fresh examination, the brain should be fixed and sliced, gross examination of the entire brain should be conducted (including multiple cross sections), and multiple specimens of tissue should be obtained (from different parts of the brain) for histological examination. Exclude potential donors when any possible evidence of TSE-related changes is observed on histological examination. There are currently no FDA-licensed, approved, or cleared donor screening tests for prions.

snip...

19. Persons who have been diagnosed with vCJD or any other form of CJD (Refs. 3 and 75).
Note: Numbers 19 to 26 in this section are designed to screen for TSEs, including CJD and vCJD. If the living donor or the individual knowledgeable about the donor’s medical and travel history is not familiar with the term "Creutzfeldt-Jakob Disease"

Contains Nonbinding Recommendations 19

or "variant Creutzfeldt-Jakob Disease," you may try to describe those in layman’s terms. If the person being interviewed is still not familiar with those terms, you may consider the lack of familiarity with those terms as a negative response to questions using those terms.


20. Persons who have been diagnosed with dementia or any degenerative or demyelinating disease of the central nervous system or other neurological disease of unknown etiology (Refs. 3 and 75). Potential donors who have a diagnosis of delirium (e.g., delirium caused by toxic/metabolic diseases or recent head trauma) would not necessarily be considered to have a diagnosis of dementia and should be evaluated by the Medical Director. (HCT/Ps from donors with dementia confirmed by gross and microscopic examination of the brain to be caused by cerebrovascular accident or brain tumor and who are confirmed not to have evidence of TSE on microscopic examination of the brain may be acceptable based on an evaluation by the Medical Director).


21. Persons who are at increased risk for CJD (Refs. 3 and 75). Donors are considered to have an increased risk for CJD if they have received a non-synthetic dura mater transplant, human pituitary-derived growth hormone, or have one or more blood relatives diagnosed with CJD (see criterion 22 of this section).


22. Persons who have a history of CJD in a blood relative (Refs. 3 and 75) unless:


• The diagnosis of CJD was subsequently found to be an incorrect diagnosis;


• The CJD was iatrogenic; or


• Laboratory testing (gene sequencing) shows that the donor does not have a mutation associated with familial CJD.


23. Persons who spent three months or more cumulatively in the United Kingdom (U.K.) (see Appendix 5) from the beginning of 1980 through the end of 1996 (Refs. 3 and 75).


24. Persons who are current or former U.S. military members, civilian military employees, or dependents of a military member or civilian employee who resided at U.S. military bases in Northern Europe (Germany, Belgium, and the Netherlands) for 6 months or more cumulatively from 1980 through 1990, or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) for 6 months or more cumulatively from 1980 through 1996 (Refs. 3 and 75).


25. Persons who spent 5 years or more cumulatively in Europe (see Appendix 5) from 1980 until the present (note this criterion includes time spent in the U.K. from 1980 through 1996) (Refs. 3 and 75).


26. Persons who received any transfusion of blood or blood components in the

Contains Nonbinding Recommendations 20


U.K. or France between 1980 and the present (Refs. 3 and 75).

snip...

Contains Nonbinding Recommendations 64

APPENDIX 5

LIST OF BSE-AFFECTED COUNTRIES APPLICABLE TO DONOR DEFERRAL

European Countries to be Used for Deferral of Donors Based on Geographic Risk of BSE

Albania, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Liechtenstein, Luxembourg, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, United Kingdom1, and Yugoslavia.

1For purposes of this guidance, the United Kingdom should include all of the following: England, Northern Ireland, Scotland, Wales, the Isle of Man, the Channel Islands, Gibraltar, and the Falkland Islands.

snip...

full text 71 pages ;

http://www.fda.gov/cber/gdlns/tissdonor.pdf

3. Food and Drug Administration, Draft Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps), dated May 2004. http://www.fda.gov/cber/gdlns/tissdonor.htm.

4. Food and Drug Administration, Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), dated June 2002.

http://www.fda.gov/cber/guidelines.htm

75. Food and Drug Administration, Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products dated January 2002.

http://www.fda.gov/cber/guidelines.htm

Greetings,

I find it deeply disturbing that the USA is NOT ON THE LIST OF BSE-AFFECTED COUNTRIES APPLICABLE TO DONOR DEFERRAL. WITH sporadic CJD on the rise in the USA, with BASE and BSE in the USA bovine, with BASE pathology not looking like nvCJD but in fact resembling that of sporadic CJD, with UNKNOWN strains showing up in the USA, with the USA having the most documented TSE in different species, more so than any other country in the world, with failures in previous deferral questionnaire for just nvCJD victims that traveled overseas for years, with the USDA failing for years and years BSE surveillance and the mad cow feed ban, it is not scientific or logical to ignore the USA donor as a risk factor for a human TSE. ...TSS

18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...

64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.

Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.


snip...

http://www.seac.gov.uk/minutes/95.pdf


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.

***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.***


6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp


SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resources-casereport.html

There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.

He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf


----- Original Message -----
From: Terry S. Singeltary Sr.
To: [log in to unmask]
Sent: Sunday, December 10, 2006 8:50 PM
Subject: Re: [CJDVoice] NIH Researcher Pleads Guilty to Improperly Taking Fees


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=12771

----- Original Message -----
From: Terry S. Singeltary Sr.
To: jgoodman@cber.fda.gov
Sent: Friday, September 01, 2006 2:49 PM
Subject: RE- FDA FORMS TASK FORCE ON HUMAN TISSUE SAFETY


http://www.microbes.info/forums/index.php?showtopic=375

http://lists.iatp.org/listarchive/archive.cfm?id=119823


http://mad-cow.org/~tom/dec99_news.html#bbb


Subject: Biomedical Tissue Services (BTS) THE BODY SNATCHERS and mad cow disease i.e. CJD and other dangerous pathogens
Date: December 20, 2005 at 2:05 pm PST

Greetings BSE-L et al;


well, the 'dear unlucky john recipient' letters are in the mail, while these company's are laughing all the way to the bank. ...TSS


Biomedical Tissue Services (BTS) THE BODY SNATCHERS and mad cow disease i.e. CJD and other dangerous pathogens

Body snatchers tied to allograft firms?
Alleged New York-area ring investigated for selling parts to corpse tissue harvesters.
October 7, 2005: 2:54 PM EDT
By Aaron Smith, CNN/Money staff writer


NEW YORK (CNN/Money) - A Brooklyn funeral home and a New Jersey company that harvests body parts from corpses are being investigated for their alleged roles in a body snatching ring that sold parts to companies specializing in medical grafts, sources close to the investigation said Friday.

The Brooklyn district attorney's office declined to comment on the investigation. But sources close to the investigation acknowledged that it has been going on for about one and a half years, focusing on Michael Mastromarino of Biomedical Tissue Services Ltd. of Fort Lee, N.J., who allegedly harvested body parts illegally from the Daniel George funeral home in Brooklyn.

The firms that bought the allegedly black-market tissue have not been accused of any wrongdoing. Human tissue is usually obtained from non-profit tissue banks. In the U.S., it's illegal to buy and sell human tissue.

Wendy Crites-Wacker, spokeswoman for Regeneration Technologies (down $0.66 to $7.28, Research), a company in Alachua, Fla., said her company has severed all ties with Biomedical Tissue Services, their former source for some of the body parts used to make medical grafts, or allografts.

"We had previously terminated the relationship with Biomedical Tissue Services and we are cooperating with the appropriate authorities on this issue," said Crites-Wacker, who declined to say when the termination took place.

Crites-Wacker also said that her company's BioCleanse process, in which bones and tendons are sterilized through a melange of chemicals, temperature and pressure, ensures that its products are safe.

Two other allograft companies have been identified as customers of Biomedical Tissue Services: LifeCell Corp. (down $2.82 to $17.33, Research), of Branchburg, N.J. and Tutogen Medical Inc. (down $0.15 to $4.06, Research) of West Paterson, N.J.

LifeCell Corp. had issued a Friday statement saying it had voluntarily recalled some human tissue products after questions were raised about Biomedical Tissue Services.

"Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS)," LifeCell said in a release.

LifeCell, which markets products made from human tissues that are used in surgical procedures, said it recalled certain AlloDerm, Repliform and GraftJacket products on Sept. 30.

LifeCell's stock price slid about 5 percent this morning, and a Piper Jaffray analyst attributed the slump to a New York Daily News story that first reported on the investigation.

"We believe this morning's weakness in LifeCell's shares is related to a news article that alleges LifeCell inadvertently received tissue from an illegal body-snatching ring," said Raj Denhoy of Piper Jaffray, in a written report.

LifeCell said in the statement all other tissues supplied by Biomedical Tissue Services remain "on hold until the discrepancies in the donor documentation can be resolved."

Denhoy said that LifeCell did not appear to do anything illegal and that "LifeCell itself was the victim of fraud," referring to allegations that Biomedical Tissue Services forged death certificates and family consent forms.

Denhoy said that LifeCell receives tissue from 30 sources, "so the loss of one will likely not impact the underlying business," though increased regulatory scrutiny could drive down the stock price.

"While LifeCell and the other tissue companies appear to have done nothing wrong, this event could increase regulatory and media scrutiny of the business," said Denhoy, who rates the company market perform. "We recently downgraded LifeCell shares on competitive concerns and today's revelations may pressure the stock further."

Eric Franz, the attorney representing funeral home owners Debora Johnson and Robert Nelms, said his clients "did not participate in any criminal conduct whatsoever."

Attempts to reach Mastromarino and his company Biomedical Tissue Services were unsuccessful. The Daily News reported that Mastromarino declined to comment.

Regeneration Technologies produces heart valves, bone and tendon implants and bone paste, which is used to plug holes. LifeCell specializes in AlloDerm, a "dermal matrix" made from human skin that is used in grafts. Tutogen focuses on bone and dental implants.

--from staff and wire reports


http://money.cnn.com/2005/10/07/news/midcaps/corpse/?section=money_latest


FDA News
FOR IMMEDIATE RELEASE
P05-77
October 26, 2005
Media Inquiries:
Julie Zawisza, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Provides Information on Investigation into Human Tissue for Transplantation
The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue may have been implanted into patients from early 2004 to September 2005. The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. At this time, the implicated tissues from BTS include human bone, skin, and tendons. These products represent only a small percentage of the overall U.S. tissue supply.

While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown.

FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.

The following tissue processors received tissue from BTS:

LifeCell Corporation of Branchburg, NJ
Lost Mountain Tissue Bank of Kennesaw, GA
Blood and Tissue Center of Central Texas in Austin, TX
Tutogen Medical, Inc., of Alachua, FL
Regeneration Technologies, Inc., of Alachua, FL
These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility.

FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed.

Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at http://www.fda.gov/medwatch.


http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html

Recall of Human Tissue


DATE RECALL INITIATED:

October 13, 2005

PRODUCT:

Human Tissue for Transplantation

MANUFACTURER:

Biomedical Tissue Services, Ltd
Fort Lee, New Jersey

REASON:

Biomedical Tissue Services (BTS) was recently made aware that there is the possibility that tissue has been procured from donors without proper medical/social histories. BTS is performing a voluntary recall of any unused tissue from its consignees.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.


Updated October 18, 2005


http://www.fda.gov/cber/recalls/btstis101305.htm


Tutogen Medical Tissue Recall

Frequently Asked Questions and Answers

Q: What prompted this recall?

A: Tutogen was unable to verify donor consent for certain tissue provided by one of its recovery agency suppliers (BioMedical Tissue Services of Fort Lee, NJ). Tutogen, along with several other tissue processing companies, received allograft material from BioMedical Tissue Services. One of these other processing companies notified Tutogen that they were having difficulty in reaching persons taking the consent information or next of kin for BioMedical tissue donors. Upon receiving this notification, Tutogen immediately initiated a review and investigation of all donor consents received from BioMedical Tissue Services. Tutogen also experienced problems in contacting consent takers, witnesses and next of kin shown on the documentation provided by BioMedical Tissue Services. We further attempted to contact Dr. Michael Mastromarino, CEO and Executive Director of BioMedical Tissue Services, to assist in this matter, but without success. Although Tutogen does not believe that there are any safety concerns related to this tissue, the company elected to initiate a voluntary recall of products incorporating the BioMedical tissues, on ethical grounds.

Q: What tissue products are being recalled?

A: Specific serial/lot numbers of Tutogen’s Puros® Allograft Cancellous Particles (marketed by Zimmer Dental) and a small quantity of Tutoplast® Fascia Lata (marketed by Mentor Corporation and Innovative Opthalmic Products, Inc.) are involved in this recall.

Q: How much allograft tissue did BioMedical Tissue Services provide to Tutogen?

A: The quantity of tissue received from BioMedical represents a small fraction (about 2%) of all tissue processed by Tutogen.

Q: What did Tutogen do to notify customers of the recall?

A: Upon completion of its donor documentation investigation, Tutogen notified the FDA of our intent to initiate a voluntary recall. We immediately identified all BioMedical tissue, from raw material stock through finished goods and field distribution, and quarantined all material within our control. Customer shipment information was assembled and a recall letter was prepared and approved by the FDA. Initially, Tutogen alerted all customers of record via telephone, describing the reason for the recall, providing serial numbers of product shipped to them and indicating the process for the return and replacement of affected product.

Simultaneously, copies of the recall letter and distribution information for the affected product was sent to each customer by facsimile. This same information was then provided to customer accounts by certified mail. At the request of the FDA, Tutogen sent a recall follow-up letter to affected customers, including FDA mandated language regarding patient notification and access to disease testing.

An additional letter was prepared and mailed to those customers that had not received any of the products manufactured using BioMedical tissue and were not affected by the voluntary recall. In the interim, the company prepared and issued a press release concerning this recall and participated in numerous conference calls, throughout the U.S. and Canada, with surgeon groups, industry organizations (such as the American Association of Tissue Banks) and professional associations (such as the American Association of Oral and Maxillofacial Surgeons and the American Academy of Periodontology).

These prior communications were supplemented by a scientific dissertation mail-out that described the Tutogen Tutoplast® process, which subsequently led to the preparation of a technical monograph detailing this process and its qualification history. The monograph may be accessed on this website by selecting the link entitled, "The Tutoplast® Process: A Review of Efficacy".

Q: How can I tell whether I received any of the affected product?

A: All customers of record, that received products manufactured utilizing tissue provided by BioMedical, were notified and should have received an individualized list of all product serial numbers shipped to them. Affected product may also be quickly identified by visually checking the alpha-numeric designator beneath the product barcode label (see samples, shown below).

The affected product alpha-numeric code begins with the letters "BM" or "BT".

Q: How should I go about returning affected product that may remain in my inventory stock?

A: Once any affected product has been identified, place it in a shipping container and mark the outside of the container with "BMRECALL". Address the package to:

Tutogen Medical

13709 Progress Boulevard

South Wing

Alachua, FL 32615

Biomedical Tissue Services

Biotissue Recovery Services

Call UPS at (800) PICK UPS and request a package pick-up. Forward the package to Tutogen, via UPS ground, using account number Y6X706. This shipping account number is reserved for the return of recalled items and is for one-way service to Tutogen, from U.S. accounts. Only product affected by this recall will be accepted for return.

Canadian customers should contact Zimmer Dental Corporation Customer Service at (800) 265-0968 or (905) 567-2073 for return instructions.

Q: What is the risk to patients that have already received recalled implants?

A: The FDA and CDC have indicated that they believe the overall risk of disease transmission by these products is low, but unknown. Because Tutogen’s Tutoplast® tissue preservation and sterilization process is extremely rigorous and has passed significant challenge testing, we believe that all tissue distributed by Tutogen, including that from BioMedical Tissue Services, is safe and effective for its intended use. In addition, comprehensive physical examination and serology testing is routinely performed on all donors processed by Tutogen.

Q: What types of evaluations are performed on donors processed by Tutogen Medical?

A: Consent for donation, along with a detailed medical/social history, is obtained from each donor or their next of kin by hospital, medical examiner, funeral home or recovery agency personnel. The recovery team identifies the donor and conducts a detailed physical evaluation of the body. This examination incorporates an extensive assessment checklist for characteristics that would disqualify a donor from further consideration and addresses tissue appearance and condition during the retrieval process. The recovery team also collects a donor blood sample and forwards it to a third-party CLIA certified laboratory for disease testing, using FDA approved test methodology. The serology test results, along with the previously mentioned donor documentation, is examined by Tutogen’s Quality Assurance Department and a staff Medical Director (a licensed physician). Only after these thorough reviews are completed and release is granted by the Medical Director, is donor tissue allowed to enter the Tutoplast® process.

Q: What testing is done on the donor serology sample?

A: Tutogen requires that the following serology testing be performed and found to be "negative" or "non-reactive", prior to accepting any donor tissue for processing:

Hepatitis B surface antigen (HBsAg)

Hepatitis B core antibody (HBcAb – IgG +IgM)

Hepatitis C Virus antibody (HCV Ab)

Hepatitis B and C Nucleic Acid Testing (HBV and HCV NAT)

Human Immunodeficiency Virus I and II antibodies (HIV I and II Ab)

HIV I – p24

Human T-Lymphotropic Virus I and II (HTLV I and II Ab)

Syphilis – Rapid Plasma Reagin (RPR/STS)

Q: Who will pay for the cost of disease testing for my patients?

A: Although Tutogen does not feel that the products manufactured using BioMedical tissue pose a safety concern, out of respect for your patients’ welfare and as a service to you, Tutogen has elected to bear the cost of the appropriate infectious disease testing.

Q: What process has Tutogen put in place to accomplish the disease testing"?

A: We have made arrangements with ViroMed Laboratories (division of LabCorp), a respected, CLIA and FDA certified organization, to conduct this testing. Should you choose to inform those patients who received the affected implants, we suggest that you offer them the opportunity to be tested for the specified infectious diseases. Additionally, we recommend that you maintain a record of notification for each patient, which would indicate their acceptance or rejection of the testing offered and be signed/dated by that individual. For those patients that elect to undergo testing, both U.S. and Canadian customers should follow the process delineated, below.


1. Provide Tutogen Medical with the name and mailing address of the patient. Only patients that received implants utilizing tissue provided by BioMedical Tissue Services are eligible for this pre-paid testing. This information will be verified in our Tissue Utilization Record (TUR) database, or you may provide documentation confirming the patient’s implant, if no TUR was previously forwarded to Tutogen.


2. Let the patient know that a test kit will be sent to him or her by ViroMed Laboratories within the next few days and will include instructions on how to proceed.


3. Instruct the patient to set up an appointment with and take the test kit to their Primary Care physician. Alternatively, the patient may elect to visit a LabCorp service center as indicated in item # 7, below.


4. Following the instructions provided with the kit, the Primary Care physician or professional healthcare office staff member should obtain a blood sample from the patient and forward it to ViroMed Laboratories in the postage-paid mailer that will be included in the kit.


5. ViroMed Laboratories will perform the appropriate disease testing and forward the results to the patient’s Primary Care physician. If a confirmatory test is necessary, ViroMed Laboratories will automatically perform this additional testing and include those results in the final test report.


6. Upon receipt of the ViroMed data, the Primary Care physician should contact the patient and discuss the final results of the testing with him or her.


7. In the event that your patient does not have a Primary Care physician, he or she may go to a "walk-in" clinic to have a blood sample taken or to be referred to a LabCorp service


center near them and have this blood sample drawn and forwarded to ViroMed Laboratories for testing. The attending physician may call ViroMed Client Services, at (800) 582-0077, to arrange for a test kit or to obtain instructions for handling the sample. These patients must have their eligibility verified by Tutogen. LabCorp or ViroMed will provide all associated test kit supplies. A list of service center locations is available on the LabCorp website (www.labcorp.com ) under the "Patient Service Center Locator" link.

If you have a patient that has already presented for infectious disease testing, a reimbursement request for costs not covered by the individual’s insurance carrier can be made by forwarding the invoice, showing the net responsibility of the patient, or a receipt, marked "Paid" to:

Tutogen Medical, Inc.

Accounts Payable

13709 Progress Blvd., Box 19

Alachua, FL 32615

The invoice should clearly show the name and address of the facility performing the disease testing and be annotated with the name of the patient’s dentist/oral surgeon and practice name, as well as the identifier, "BMRECALL".

Q: What testing will be performed on each patient’s blood sample?

A: The recommended testing is for HIV I and II, Hepatitis B virus, Hepatitis C virus and syphilis. All test results will remain confidential, between patient and doctor.

Q: Is Tutogen still receiving tissue from BioMedical Tissue Services?

A: No. Upon initiating the voluntary recall, Tutogen suspended the acceptance of any tissues from BioMedical Tissue Services and has officially terminated its relationship with them.

Q: How can a situation such as this be prevented in the future?

A: At this point, there is no simple answer to this question. Tutogen adhered to all of its standard screening, inspection and processing procedures and there was no deviation or departure from its quality assurance systems. All processing companies rely on the FDA registered and state licensed recovery agencies to comply with established regulations and industry guidelines. Tutogen is currently evaluating a number of potential additional safeguards, but no mechanisms have been identified that would provide a foolproof solution. In addition, we are working very closely with the Food and Drug Administration and American Association of Tissue Banks to devise workable options that might preclude recurrence.


http://www.tutogen.com/recallQandA.pdf


Recall of Human Tissue Products


DATE RECALL INITIATED:

October 14, 2005

PRODUCT:

Human Tissue For Transplantation

MANUFACTURER:

Regeneration Technologies, Inc
Alachua, Florida

REASON:

Regeneration Technologies, Inc. (RTI) is conducting a voluntary recall of all tissue received from BioMedical Tissue Services (BTS; Ft. Lee, New Jersey) as a result of information regarding the accuracy of donor screening documentation. RTI informed its consignees that a lack of assurance of donor identity as well as the risk of infectious diseases also exists. Consignees are asked to contact the manufacturer to arrange for product return.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.


Updated October 18, 2005


http://www.fda.gov/cber/recalls/rtitis101405.htm


FDA News
FOR IMMEDIATE RELEASE
P05-77
October 26, 2005
Media Inquiries:
Julie Zawisza, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Provides Information on Investigation into Human Tissue for Transplantation
The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue may have been implanted into patients from early 2004 to September 2005. The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. At this time, the implicated tissues from BTS include human bone, skin, and tendons. These products represent only a small percentage of the overall U.S. tissue supply.

While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown.

FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.

The following tissue processors received tissue from BTS:

LifeCell Corporation of Branchburg, NJ
Lost Mountain Tissue Bank of Kennesaw, GA
Blood and Tissue Center of Central Texas in Austin, TX
Tutogen Medical, Inc., of Alachua, FL
Regeneration Technologies, Inc., of Alachua, FL
These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility.

FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed.

Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at http://www.fda.gov/medwatch.

Additional information is available on FDA’s web site at http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.

####


http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html


Recall of Human Tissue Products


DATE RECALL INITIATED:

October 11, 2005

PRODUCT:

Human Tissue for Transplantation

MANUFACTURER:

The Blood and Tissue Center of Central Texas
Austin, Texas

REASON:

Central Texas Regional Blood and Tissue Center is voluntarily recalling tissue products as the firm is unable to confirm information provided by BioMedical Tissue Services (BTS; Ft. Lee, New Jersey). Consignees are asked to contact the manufacturer to arrange for product return.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.


Updated October 18, 2005


http://www.fda.gov/cber/recalls/blotis101105.htm


Recall of Human Tissue Products


DATE RECALL INITIATED:

October 12, 2005

PRODUCT:

Human Tissue for Transplantation

MANUFACTURER:

Tutogen Medical, Inc.
Alachua, Florida

REASON:

Tutogen Medical is conducting a voluntary recall of all materials that were manufactured utilizing BioMedical Tissue Services (BTS; Ft. Lee, New Jersey) donor tissue. This action is being taken because Tutogen is unable to satisfactorily confirm that donor eligibility had been properly obtained by BTS. Tutogen informed its consignees that there is a lack of assurance that appropriate donor identification, donor screening, and medical history data collection was performed and, therefore, a risk of infectious disease exists. Consignees are asked to contact the manufacturer to arrange for product return.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.


Updated October 18, 2005


http://www.fda.gov/cber/recalls/tutotis101205.htm


Withdrawal of Human Tissue Products


DATE WITHDRAWAL INITIATED:

October 10, 2005

PRODUCT:

Human Tissue for Transplantation

MANUFACTURER:

Lost Mountain Tissue Bank
Kennesaw, Georgia

REASON:

Lost Mountain Tissue Bank, Inc. (LMTB) has initiated consignee notifications for all tissue products processed and/or distributed from donors procured in the New York area by Biomedical Tissue Services (BTS; Ft. Lee, New Jersey). LMTB was informed of some discrepant and possibly fraudulent information in donor documentation. LMTB is notifying all relevant hospitals and medical professionals of the market withdrawal of all tissue products beginning with the letters “GL” or “T” in the tissue identification number (ID#).


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.


Updated October 18, 2005


http://www.fda.gov/cber/recalls.htm


DATE RECALL INITIATED:

September 30, 2005

PRODUCT:

AlloDerm, Repliform, and GraftJacket

MANUFACTURER:

LifeCell Corporation
Branchburg, New Jersey

REASON:

LifeCell Corporation initiated a voluntary recall of certain AlloDerm, Repliform, and GraftJacket product from the marketplace on September 30, 2005. The recall was prompted when internal quality processes raised questions about the donor documentation received from one tissue recovery organization. Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS). Life Cell promptly notified the FDA and all relevant hospitals and medical professionals. All other BTS inventory remains on hold until the discrepancies in the donor documentation can be resolved. LifeCell works with more than 40 other tissue recovery organizations that are not affected by this recall.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Updated October 12, 2005


http://www.fda.gov/cber/recalls/tislife093005.htm


Compliance Program
Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
7341.002


http://www.fda.gov/cber/cpg/7341002tis.htm

----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Thursday, October 27, 2005 9:55 AM
Subject: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA


##################### Bovine Spongiform Encephalopathy #####################

From: TSS ()
Subject: THE LEGAL TRADING AND SELLING OF BODY PARTS AND HUMAN TSEs IN THE USA
Date: October 27, 2005 at 8:40 am PST

WASHINGTON
FDA investigating human tissue sales
WASHINGTON - The Food and Drug Administration said Wednesday that it is investigating a New Jersey-based company that sold human tissue to processors for eventual implantation into people, because it may not have been properly screened for infections. The New York Daily News reported earlier this month that the district attorney's office in Brooklyn, N.Y., is investigating the company, Biomedical Tissue Services of Fort Lee, N.J., on allegations that the company illegally bought body parts from funeral homes to sell to tissue processors. An FDA spokeswoman would not comment on those allegations. The tissues include human bones, skin and tendons and constitute only a small portion of the U.S. tissue supply, the FDA said. They were implanted between early 2004 and September 2005. The Blood and Tissue Center of Central Texas in Austin received some.

http://www.chron.com/cs/CDA/ssistory.mpl/nation/3419112


FOR IMMEDIATE RELEASE
P05-77
October 26, 2005
Media Inquiries:
Julie Zawisza, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Provides Information on Investigation into Human Tissue for Transplantation
The Food and Drug Administration (FDA) is notifying the public of its investigation of human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and sent to tissue processors. Some of this tissue may have been implanted into patients from early 2004 to September 2005. The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. At this time, the implicated tissues from BTS include human bone, skin, and tendons. These products represent only a small percentage of the overall U.S. tissue supply.

While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown.

FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.

The following tissue processors received tissue from BTS:

LifeCell Corporation of Branchburg, NJ
Lost Mountain Tissue Bank of Kennesaw, GA
Blood and Tissue Center of Central Texas in Austin, TX
Tutogen Medical, Inc., of Alachua, FL
Regeneration Technologies, Inc., of Alachua, FL
These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility.

FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed.

Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at http://www.fda.gov/medwatch.

Additional information is available on FDA’s web site at http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.

####


http://www.fda.gov/bbs/topics/NEWS/2005/NEW01249.html


a bit of history;


The Eyes have it/CJD * and they could be stealing them from YOUR loved
one, hence the spread of CJD (aka MADCOW DISEASE) will spread...


############ Creutzfeldt-Jakob Disease
#############

Greetings list members, I was impressed that someone is listening,
considering the timing of when I broke the story in Nov. and this was
posted in Dec., what a coincidence. Thanks for listening. I find it
rather frightening of the fact sporadic CJD as well as vCJD can

transmit infectivity this way. Makes me wonder about blood?
Kind Regards, Terry S. Singeltary Sr., Bacliff, Texas USA

Vol. 282 No. 23, December 15, 1999
Preventing Prion Transmission in Corneal Transplants


http://www.vegsource.com/talk/madcow/messages/7242.html


Cadaver corneal transplants -- without family permission

Houston, Texas channel 11 news 28 Nov 99
Reported by Terry S. Singeltary Sr. son of CJD victim

http://mad-cow.org/~tom/dec99_news.html#bbb


VOL. 282 No. 23, December 15, 1999

Preventing Prion Transmission in Corneal Transplants

To the Editor: We agree with the Council on Scientific Affairs' recommendation that "physicians become knowledgeable about BSE [bovine spongiform encephalopathy] so they can appropriately advise their patients about routes and rates of BSE transmission."1 Unfortunately, there is only passing mention of prion transmission by corneal transplantation, which is performed on 40,000 to 50,000 patients each year in the United States.2 In addition to the 1974 US case,3 2 additional cases of probable and possible transmission, respectively, have been reported in Germany and Japan,3 but the major new concern relative to prion transmission via corneas occurred recently in Great Britain. In February 1997, the corneal transplant and sclera from a 53-year-old woman who had died of presumed metastatic lung cancer were transplanted to 3 recipients.4 In November 1997, the donor's brain revealed sporadic Creutzfeldt-Jakob disease (CJD), confirmed by the United Kingdom CJD Surveillance Unit.4 . . . [Full Text of this Article]


http://jama.ama-assn.org/cgi/content/extract/282/23/2211?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=CJD+EYE&searchid=1130425573446_2695&stored_search=&FIRSTINDEX=0&journalcode=jama


http://www.vegsource.com/talk/madcow/messages/7643.html


http://www.vegsource.com/talk/madcow/messages/7708.html


VVOL

http://mad-cow.org/~tom/dec99_news.html#bbb


Testimony of Bess Believeaux, Lions Eye Bank of Central Texas
(Submission to the Jan. 18/19 meeting of the TSE Advisory Committee)


http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_16.pdf


TSS Submission to the same Committee;


http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf


Tissue Banks International (TBI), Gerald J Cole


http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_13.pdf


re-use contact lenses


http://www.vegsource.com/talk/madcow/messages/7691.html


TSS


Link: Reported by Terry S. Singeltary Sr. son of CJD victim 28 Nov 99 THE EYES HAVE IT, CJD...


#################### https://lists.aegee.org/bse-l.html ####################


Update on Donor Screening
for TSEs
Melissa A. Greenwald, MD
Division of Human Tissues
Office of Cellular, Tissue and Gene Therapies
AATB 29th Annual Meeting
Hollywood, Florida
Council of Accredited Tissue Banks
Tuesday 20 September 2005
Today’s talk will focus on:
• What are Transmissible Spongiform
Encephalopathies (TSEs)?
• Background on CJD/vCJD Draft
Guidance
• Specific recommended deferral criteria
• Allow time for discussion and
questions
What are TSEs?
• Human Transmissible Spongiform
Encephalopathies (TSEs) include
Creutzfeldt Jakob Disease (CJD) and
variant Creutzfeldt Jakob Disease
(vCJD)
• CJD has been a known agent, but
vCJD has only been identified in the
recent past—is a human form of
Bovine Spongiform Encephalopathy
(BSE), known as “mad cow disease”
What are TSEs? (cont.)
• The TSE agent is a prion–a poorly
understood agent; is an abnormal
protein that causes a degenerative
disease of the central nervous
system (CNS) that is not curable and
invariably leads to the death of the
person with the disease
• The agent is very difficult to destroy
and would not be inactivated by
current tissue processing technology
What are TSEs? (cont.)
• Blood from some animals
experimentally infected with TSE
agents, including the BSE agent,
contains low levels of infectivity
• Several TSE agents, including BSE,
have been experimentally
transmitted by transfusion
• Agent for vCJD is ingested, so it is
likely that the agent has a bloodborne
phase in humans (the
specifics of the pathology in humans
is poorly understood)
What are TSEs? (cont.)
• There are no published studies
showing transmission of the BSE
agent via HCT/Ps; however
• vCJD agent is present in lymph
nodes and tonsils of infected
patients
• vCJD has been transmitted via blood
transfusion in the UK
• Transmission of CJD via cornea and
dura mater has already been
demonstrated in humans
What are TSEs? (cont.)
• Because of studies showing blood
infectivity of TSE agents, it is a
theoretical risk that HCT/Ps have the
potential to transmit TSEs
• Because of this theoretical risk, FDA
is concerned about the potential for
transmission of TSEs via HCT/Ps
and therefore considers TSEs a
RCDAD and requires donor
screening for these agents
CJD/vCJD draft guidance
• Deferral of tissue donors for risk
factors for “classic” (sporadic)
CJD—already recommended in the
1997 guidance for industry
• The draft guidance for CJD/vCJD
incorporated those deferrals, and in
addition recommends deferrals for
risk factors for variant CJD—travel or
residence in BSE-affected countries
• The draft guidance published June
2002
• There was a 6 month comment
CJD/vCJD draft guidance
• Draft guidance was modeled after the
guidance for industry for blood
donors, issued August 2001
• Recommends the same countries,
dates, and lengths of
travel/residence as does the
guidance for blood donors
• Permits an exception for the
collection and storage of
hematopoietic stem cells from
donors who live in or travel to a BSEaffected
country (for urgent medical
CJD/vCJD draft guidance
• Comments reviewed at CBER
• Final recommendations for
CJD/vCJD screening will be
incorporated into the final Donor
Eligibility guidance when published
• As of May 25, 2005 Transmissible
Spongiform Encephalopathy (CJD
and vCJD) is a relevant
communicable disease agent or
disease (RCDAD) and establishments
must screen for CJD/vCJD
CJD/vCJD draft guidance
• Specific deferral criteria in the draft
guidance are an indication of FDA’s
current thinking about how to
adequately and appropriately reduce
the risk of infectious disease
transmission by this agent
• Until a final guidance is issued,
establishments would not
necessarily have to “adopt” the
recommended deferral criteria but
the regulations do require some
screening for TSEs (including CJD
and vCJD)
CJD/vCJD draft guidance
• May use alternate screening criteria as long
as the screening criteria are at least as strict
as those recommended by FDA (i.e., are as
effective to adequately and appropriately
reduce the risk of infectious disease
transmission)
• No testing recommendations made—there
are no FDA approved tests for humans
CJD/vCJD Risks for Donor
Screening
• Persons who have been diagnosed
with vCJD or any other form of CJD
• Persons who have been diagnosed
with dementia or any degenerative or
demyelinating disease of the CNS or
other neurological disease of
unknown etiology [Possible that
FDA may make a distinction between
dementia and acute delirium (e.g.,
delirium caused by toxic/metabolic
disease or recent head trauma)]
Donor Screening (cont.)
• Persons who are at increased risk for CJD
– Receipt of human dura mater transplant
– Receipt of human pituitary-derived growth
hormone
– One or more blood relatives diagnosed with
CJD
• Persons who spent three months or more
cumulatively in the U.K. from the
beginning of 1980 through the end of 1996
Donor Screening (cont.)
• Persons who are current or former
U.S. military members, civilian
military employees, or dependents of
a military member or civilian
employee who resided at U.S.
military bases in Northern Europe for
6 months or more from 1980 through
1990, or elsewhere in Europe for 6
months or more from 1980 through
1996
Donor Screening (cont.)
• Persons who lived cumulatively for 5
years or more in Europe between
1980 and the present
• Persons who received any
transfusion of blood or blood
components in the U.K. between
1980 and the present
• NOTE—If the person being
interviewed is not familiar with the
term CJD, you may take that as a
negative response
The UK
• For the guidance, the UK includes
– England
– Northern Ireland
– Scotland
– Wales
– Isle of Man
– Channel Islands
– Gibraltar
– the Falkland Islands.
Military Bases
• In Northern Europe includes
– Germany, UK, Belgium, Netherlands
– Deferral from 1980-1990
• In Southern Europe includes
– Greece, Turkey, Spain, Portugal, Italy
– Deferral from 1980-1996
Family History of CJD
• Would be ineligible UNLESS:
– the diagnosis of CJD was subsequently found
to be an incorrect diagnosis;
– the CJD was iatrogenic; or
– laboratory testing (gene sequencing) shows
that the donor does not have a mutation
associated with familial CJD
For further information
http://www.fda.gov/cber/gdlns/cjdvcjd0602
.htm
Melissa Greenwald
301-827-2002
melissa.greenwald@fda.hhs.gov
Vox Sang. 89(2) pp. 63-70.


http://www.fda.gov/cber/summaries/aatb092005mg.pdf


what does this week have in store for recipients of donor tissue;


PRODUCT
Acellular Dermal Matrix Skin Tissue, Recall # B-0276-6
CODE
Alloderm
B10084-002, B10084-007, B10084-009, B10084-012 thru 014, B10084-017 and 018, B10084-023, B10084-025 thru 029, B10085-001 and 002, B10085-007 thru 012, B10085-017, B10085-021 thru 025, B10088-001, B10088-006 thru 009, B10088-010 thru 021, B10088-025 thru 035, B10134-001 thru 004, B10134-010 and 011, B10134-017 thru 026, B10192-007 and 008, B10192-012, B10192-016 and 017, B10192-019, B10192-024 and 025, B10192-028 thru 035, B10222-001, B10222-005 and 006, B10222-014 and 015, B10222-017 thru 020, B10222-022 thru 024, B10222-026, B10222-028, B10721-009 thru 012, B10721-016 thru 024, B10819-001 and 002, B10819-005 thru 007, B10819-009 thru 014, B10819-016 thru 018, B10819-031 and 032, B10819-035, B10838-007, B10838-009, B10838-018 thru 023, B10838-026 thru 028, B10850-001 thru 004, B10850-009 thru 016, B11021-001 and 002, B11021-008 thru 011, B11022-016 and 017, B11024-011 thru 013, B11024-015 thru 019, B11025-001, B11025-011 thru 016, B11025-019 thru 021, B11026-001 thru 003, B11026-010 thru 012, B11026-015, B11026-017 thru 023, B11052-003 and 004, B11052-012 and 013, B11052-015 and 016, B11054-013, B11055-003 and 004, B11055-011 and 012, B11055-017, B11055-019 and 020, B11061-002, B11061-015 thru 017, B11064-002 thru 004, B11064-013 thru 017, B11064-020, B11064-022, B11065-001 and 002, B11065-004, B11065-006 and 007, B11065-009, B11065-012 thru 018, B11079-004, B11079-013 and 014, B11079-016, B11079-019, B11079-021 thru 024, B11079-029 thru 031, B11080-002, B11080-009 thru 011, B11080-016, B11080-021, B11083-019 thru 022, B11083-024 thru 027, B11087-003 thru 005, B11087-007 thru 013, B11099-012 and 013, B11099-016 thru 026, B11103-003, B11103-008, B11103-011 thru 015, B11104-002 thru 005, B11104-009, B11107-002 thru 004, B11107-011, B11107-014 thru 020, B11107-025, B11115-003 and 004, B11115-012 and 013, B11115-018 thru 021, B11115-025 and 026, B11120-019, B11120-021, B11127-008 thru 010, B11127-013 and 014, B11129-001, B11129-009 and 010, B11129-013 and 014, B11131-011 thru 013, B11131-015 thru 017, B11148-012, B11148-016 thru 023, B11156-009, B11156-013 thru 017, B11163-002, B11163-015, B11163-017 thru 021, B11180-001, B11180-004, B11180-009 thru 012, B11180-014 and 015, B11180-017, B11181-001, B11181-003, B11181-009, B11181-011 thru 015, B11202-001 thru 004, B11202-014 thru 016, B11202-021 and 022, B11213-001, B11213-003 and 004, B11213-007, B11213-010 thru 014, B11213-022, B11217-010 thru 013, B11217-015, B11239-003, B11239-006, B11239-015, B11239-023 and 024, B11239-026, B11239-030, B11244-014, B11244-017, B11244-020, B11244-022, B11247-001, B11247-016, B11247-018, B11247-021, B11262-016, B11266-014, B11266-016, B11266-018 and 019, B11266-023, B11281-021, B11281-023, B11282-015, B11282-019, B11286-013 and 014, B11296-010 thru 013, B11296-015, B11324-027, B11324-030, B11327-014 and 015, B11349-009, B11350-012, B11350-017, B11350-019, B11363-012, B11363-015, B11367-018 thru 020, B11367-030 and 031, B11410-012 and 013, B11432-012, B11432-014, B11468-013 and 014, B7406-001 thru 031, B7406-034 thru 037, B7406-045 thru 047, B7406-050 thru 061, B7406-065 thru 067, B7406-069 thru 077, B7417-001 thru 013, B7417-015 , B7417-019 thru 023, B7417-037 thru 042, B7417-044 thru 046, B7417-048, B7417-050, B7417-054 thru 058, B7430-001 thru 014, B7430-018, B7430-020, B7430-026 and 027, B7430-035 thru 037, B7430-039 thru 079, B8410-012 thru 037, B8410-039 thru 052, B8411-002 and 003, B8411-007, B8411-014 and 015, B8411-017 thru 056, B8414-001 thru 008, B8414-015 thru 029, B8421-001, B8421-003, B8421-005 and 006, B8421-009, B8421-024 thru 048, B8421-051 thru 058, B8422-001 thru 006, B8422-008, B8422-012, B8422-018 thru 028, B8422-030 thru 032, B8422-035 thru 039, B8422-043, B8422-045 thru 047, B8422-050 and 052, B8422-054, B8424-001 thru 004, B8424-008, B8424-010, B8424-014 thru 016, B8424-022 thru 032, B8424-034 and 035, B8424-037 thru 044, B8425-010 thru 019, B8425-021 and 022, B8425-025 thru 027, B8684-001 thru 005, B8684-007 and 008, B8684-010, B8684-016 thru 030, B8684-032, B8684-034 and 035, B8684-037 thru 050, B8685-001 thru 003, B8685-011 thru 042, B8695-002 and 003, B8695-005 thru 013, B8695-023 thru 061, B8697-001, B8697-006, B8697-014, B8697-017 and 018, B8697-020 and 021, B8697-037 thru 039, B8697-041, B8697-043 thru 058, B8706-001 and 002, B8706-006 thru 009, B8706-013, B8706-019 thru 023, B8706-025 thru 048, B8707-007 thru 014, B8707-016 thru 019, B8708-008 thru 025, B8720-001, B8720-003 thru 005, B8720-009, B8720-012, B8720-021 thru 025, B8720-027 thru 033, B8720-035 and 036, B8720-038 and 039, B8720-040 , B8720-042 thru 062, B8722-002, B8722-010 and 011, B8722-017 thru 025, B8722-027 thru 042, B8723-001, B8723-004 thru 007, B8723-016, B8723-025 and 026, B8723-028 and 029, B8723-031 thru 33, B8731-013 and 014, B8731-017, B8731-021 and 022, B8731-026 thru 045, B8732-001, B8732-004 and 005, B8732-005, B8732-016 thru 024, B8732-026 thru 045, B8734-021 thru 023, B8734-027, B8734-029 thru 031, B8734-033, B8734-037 and 038, B8734-041, B8734-043 thru 053, B8734-055 thru 057, B9132-002 thru 005, B9132-010, B9132-014 thru 029, B9228-007 thru 018, B9232-004, B9232-010 and 011, B9232-016 thru 023, B9243-001, B9243-003, B9243-005, B9243-011, B9243-014, B9243-016, B9243-018 thru 027, B9245-001, B9245-009, B9245-013 and 014, B9245-014, B9245-017, B9245-019 thru 028, B9284-001 thru 005, B9284-007, B9284-011 thru 020, B9284-023 thru 026, B9284-029 thru 042, B9285-001 and 002, B9285-004, B9285-012 and 013, B9285-016, B9285-019 thru 027, B9285-029, B9322-002 thru 004, B9322-007, B9322-013 thru 022, B9322-024 thru 026, B9323-001, B9323-006 and 007, B9323-017, B9323-019 thru 030, B9331-001, B9331-004 thru 007, B9331-017, B9331-020 thru 028, B9331-031 thru 042, B9333-001 thru 003, B9333-005 and 006, B9333-012, B9333-015 thru 020, B9340-002 and 003, B9340-006 and 007, B9340-010 thru 012, B9340-014 thru 022, B9491-001 thru 003, B9491-006, B9491-011 thru 013, B9491-017 thru 023, B9509-001, B9509-012, B9509-018 thru 022, B9693-002, B9693-008 thru 015, B9725-001, B9725-005 and 006, B9725-012 thru 031, B9725-033 thru 037, B9765-002 and 003, B9765-005 thru 007, B9765-015, B9765-018 thru 022, B9927-001 thru 004, B9927-007, B9927-009 thru 011, B9927-013 thru 029, B9927-031 thru 033, C10602-016 thru 021
Repliform
B10084-019 and 020, B10084-022, B10084-024, B10134-016, B10192-013, B10192-015, B10192-018, B10192-020 thru 023, B10819-027, B11120-008 thru 11, B7406-044, B7406-048, B7406-064, B7406-078 thru 83, B7417-031 and 32, B7430-038, B8414-014, B8421-020, B8421-022 and 23, B8422-042, B8424-036, B8684-015, B8685-005 thru 8, B8697-040, B8697-042, B8706-024, B8723-019, B8723-024, B8734-042, B9232-014 and 015, B9243-015, B9245-018, B9284-027 and 028, B9285-015, B9285-017 and 018, B9333-007 and 08, B9333-010 and 011, B9509-015, B9725-007, B9765-008, C10602015
Graft Jacket
B10084-016, B10084-021, B10085-014 thru 016, B10088-023 and 024, B10134-013, B10838-015, B11021-006, B11052-010, B11065-011, B11079-009, B11087-006, B11131-008, B11148-009, B11163-016, B11163-008 and 009, B11181-010, B11266-012, B7406-062, B7417-051 thru 053, B8421-049 and 050, B8422-041, B8684-036, B8695-019, B8697-032, B8706-014, B8720-016, B8720-019, B8720-020, B8720-034, B8720-037, B8732-025, B8732-013, B9243-013, B9245-015, B9245-016, B9284-022, B9331-029 and 030, B9340-009, B9491-014, B9765-013, B9765-016
RECALLING FIRM/MANUFACTURER
LifeCell Corporation, Branchburg, NJ, by telephone and facsimile transmission beginning September 30, 2005, and by follow-up letter dated October 12, 2005. Firm initiated recall is ongoing.
REASON
Human Tissues, procured from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,652 allografts from 102 lots
DISTRIBUTION
Nationwide, Australia and Korea

http://www.fda.gov/bbs/topics/enforce/2005/ENF00932.html

NOW, LETS JUST TAKE A LOOK SEE AT TODAYS VIOLATIONS ON TISSUE FEB. 2007 ;

February 14, 2007
07-07

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS I
___________________________________


snip...

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
__________________________
PRODUCT
Human Tissue for Transplantation, Recall # B-0513-07
a) Blackstone Lumbar, 12mm, Irradiated, Lyophilized;
b) Cancellous Chips, 60cc, Irradiated, Lyophilized;
c) Fascia Lata, 20x70mm, Irradiated, Lyophilized;
d) Cancellous Cubes, 4-10mm, Irradiated, Lyophilized;
e) Left Achilles Tendon, 205 mm, Fresh Frozen, Gamma Irradiated;
f) Hemi-Patella Tendon, Fresh Frozen, Gamma Irradiated;
g) Gracilis, Fresh Frozen, Gamma Irradiated;
h) Semitendinosus, Fresh Frozen, Gamma Irradiated;
i) Blackstone Lumbar, 10 mm, Irradiated, Lyophilized;
j) Ilium Tricortical, 48x25x13mm, Irradiated, Lyophilized;
k) Fibular Strut, Fresh Frozen, Gamma Irradiated;
l) Patellar Tricortical, 15x25x18mm, Irradiated, Lyophilized;
m) Blackstone Lumbar, 8mm, Irradiated, Lyophilized;
n) Fascia Lata, Irradiated, Lyophilized;
o) Fibular Wedge 8x14mm, Irradiated, Lyophilized;
p) Cervical Allograft, 8mm Fresh Frozen, Gamma Irradiated;
q) Left Achilles Tendon, Fresh Frozen, Gamma Irradiated;
r) Frozen Skin 1/3 Sq. Ft;
s) AllOss Block Allograft, Lyophilized, Irradiated;
t) Cancellous Part. 0.5cc (1000-20000um);
u) Cancellous Part. 1.0cc (1000-2000um);
v) Cancellous Part. 2.0cc (1000-2000um);
w) Dowel, 35mm, Irradiated, Lyophilized;
x) Cortical Strut, 24x200mm, Irradiated, Lyophilized;
y) Tibial Shaft, Irradiated, Lyophilized;
z) Right Achiles Tendon, Fresh Frozen, Gamma Irradiated;
aa) Anterior Tibialis, Fresh Frozen, Gamma Irradiated;
bb) Vertebron ACIF, 7mm, Irradiated Lyophilized;
cc) Cancellous Part., 0.5cc (250-1000um);
dd) Cancellous Part, 1.0cc (250-1000um);
ee) Cancellous Part., 2.0cc (250-1000um);
ff) Biportal 8x11x25mm;
gg) Femoral Shaft, Fresh Frozen, Gamma Irradiated
CODE
a) 050404183001, 050404183002, 050404183003, 050404183004, 050404183005,
050404183006, 050404183007, 050404183008, 050404183009, 050404183010,
050404183011;
b) 0843711221, 0843711222, 0846811209, 0849011208, 0850011207;
c) 0843711903, 0843711904, 0846811915;
d) 0843721105, 0843721106, 0843721107, 0843721108, 0843721109, 0843721110,
0843721111, 0843721112, 0843721113, 0843721114, 0843721115, 0843721116,
0843721117, 0843721118, 0843721119, 0843721120, 0846821101, 0846821102,
0846821103, 0846821104, 0846821105, 0846821106, 0846821107, 0846821108,
0849021101, 0849021102, 0849021103, 0849021104, 0849021105, 0849021106,
0849021107, 0850021101, 0850021102, 0850021103, 0850021104, 0850021105,
0850021106;
e) 0843701401;
f) 0843704501, 0843704502, 0843704503, 0843704504, 0849004501, 0863604501,
0863604502, 0863604503, 0866304501, 0866304502, 0889704501, 0889704502,
0889704503, 0889704504, 0906704501, 0906704502, 0906704503, 0906704504;
g) 0843706501, 0843706502, 0846806501;
h) 0843706601;
i) 050405183001, 050405183002, 050405183003, 050405183004, 050405183006,
050405183007, 050405183008, 050405183009, 050404183012, 050404183013,
050404183014, 050404183015;
j) 0846810910, 0849010909, 0850010910;
k) 0846811511, 0846811512, 0846811513, 0866311501, 0866311502, 0866311503;
l) 0846814114, 0863414106, 0863414107, 0863514106;
m) 050433183001, 050433183002, 050405183010, 050405183011, 050405183012,
050405183013, 050405183014, 050405183015, 050405183016, 050405183017,
050405183018, 050405183019, 050405183020, 050405183021;
n) 0849011915;
o) 0849014010, 0849014011, 0849014012, 0849014013, 0849014014, 0850014008,
0850014009;
p) 050498184007;
q) 0866301401;
r) 0889300101, 0889300102, 0889300103, 0889300104, 0889300105, 0889300106,
0889300107, 0889300108, 0889300109, 0889300110, 0889300111, 0889300112,
0889300113, 0889300114, 0889300115, 0889300116, 0889300117, 0895100101,
0895100102, 0895100103, 0895100104, 0895100105, 0895100106, 0895100107,
0895100108, 0895100109, 0895100110, 0895100111, 0896600101, 0896600102,
0896600103, 0896600104, 0896600105, 0896600106, 0896600107, 0896600108;
s) 060056241001, 060056241002, 060056241003, 060056241004, 051009241078,
051009241079;
t) 060056107012, 060056107013, 060056107014, 060056107015, 060056107016,
060056107017, 060056107018, 060056107019, 060056107020, 060056107021,
060056107022, 060056107023, 060056107024, 060056107025, 060056107026,
060056107027, 060056107028, 060056107029, 060056107030, 060056107031,
060056107032, 060056107033, 060056107034, 060056107035, 051009107067,
051009107068, 051009107069, 051009107070;
u) 060056107036, 060056107037, 060056107038, 060056107039, 060056107040,
060056107041, 060056107042, 060056107043, 060056107044, 060056107045,
060056107046, 060056107047, 060056107048, 060056107049, 060056107050,
060056107051, 060056107052, 060056107053, 060056107054, 060056107055,
060056107056, 060056107057, 051009107071, 051009107072, 051009107073,
051009107074;
v) 060056107058, 060056107059, 060056107060, 060056107061, 060056107062,
060056107063, 060056107064, 060056107065, 060056107066, 060056107067,
060056107068, 060056107069, 060056107070, 060056107071, 060056107072,
060056107073, 060056107074, 060056107075, 060056107076, 060056107077,
060056107078, 060056107079, 051009107075, 051009107076, 051009107077;
w) 0889710101, 0889710102;
x) 0889711405, 0866211408;
y) 0889714507, 0889714508;
z) 0889701402, 0906701402, 0843701402;
aa) 0889706801;
bb) 051009159001, 051009159002, 051009159003, 051009159004, 051009159005,
051009159006, 051009159007, 051009159008, 051009159009;
cc) 051009107001, 051009107002, 051009107003, 051009107004, 051009107005,
051009107006, 051009107007, 051009107008, 051009107009, 051009107010,
051009107011, 051009107012, 051009107013, 051009107014, 051009107015,
051009107016, 051009107017, 051009107018, 051009107019, 051009107020,
051009107021, 051009107022, 051009107023, 060056107005;
dd) 051009107024, 051009107025, 051009107026, 051009107027, 051009107028,
051009107029, 051009107030, 051009107031, 051009107032, 051009107033,
051009107034, 051009107035, 051009107036, 051009107037, 051009107038,
051009107039, 051009107040, 051009107041, 051009107042, 051009107043,
060056107006, 060056107007, 060056107008;
ee) 051009107044, 051009107045, 051009107046, 051009107047, 051009107048,
051009107049, 051009107050, 051009107051, 051009107052, 051009107053,
051009107054, 051009107055, 051009107056, 051009107057, 051009107058,
051009107059, 051009107060, 051009107061, 051009107062, 051009107063,
051009107064, 051009107065, 051009107066, 060056107009, 060056107010,
060056107011;
ff) 060267173001, 060267173002, 060267173003, 060267173004, 060267173005,
060267173006, 060267173007, 060267173008;
gg) 0863705301, 0863705302, 0866305301
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.S. Tissue & Cell, Cincinnati, OH, by telephone on July 6, 7, 8 and 24, 2006 and by letter dated August 25, August 30, 2006 and January 2, 2007.
Manufacturers: U.S. Tissue & Cell, Cincinnati, OH, and U.S. Tissue & Cell, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Human tissues, recovered from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
352 allografts
DISTRIBUTION
Nationwide and Korea

snip...

END OF ENFORCEMENT REPORT FOR FEBRUARY 14, 2007.

###


http://www.fda.gov/bbs/topics/enforce/2007/ENF00991.html

Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

February 21, 2007
07-08

snip...

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
___________________________________
PRODUCT
Human Tissue for Transplantation, Recall # B-0549-07,
a) Achilles Tendon, Product #LATM;
b) Cancellous Bone, Chips 4-10 mm (15 cc), Product #LCIPM;
c) Iliac Crest Wedge (11-13 mm), Product #LIWMM;
d) Cervical Pre-shaped Allograft (7x11x13 mm), Product #NCAS7;
e) Semitendinosus Tendon, Product #LSTM;
f) Patella Tendon, Whole, Product #LPTWM;
g) Patella Tendon, Hemi, Product #LPTHM;
h) Cancellous Bone, Chips 4-100 mm (30 cc), Product #LCISM;
i) Femoral Head, Product #LFTNM;
j) Costal Cartilage (Rib), Product #LCAM;
k) Gracilis Tendon , Product #LGTM;
l) Unicortical Cloward Dowels, 14 mm, Product #LDIMM;
m) Tibialis Tendon, Product #LTTM;
n) Patella Tendon, Fresh Frozen, Product #LPTHFFM;
o) Iliac Crest Wedge (<10mm), Product #LIWSM,
p) Femoral Shaft, Split Block (1/pk), Product #LFSHM;
q) Fascia Lata, <120 mm, Product #LFLSM;
r) Cortical Cancellous Strips (<15 mm, 5/pk), Product #LMSM;
s) Cancellous Bone, Chips (4-10 mm, 60 cc), Product #LCILM;
t) Cancellous Bone, Chips (1-4mm, 30 cc), Product #LCCSM;
u) Lordotic Allograft Segments (8x12x22 mm), Product #LAS1222;
v) Cervical Pre-shaped Allograft (6x11x13mm), Product #NCAS6;
w) Iliac Crest Wedge (14-17 mm), Product #LIWLM;
x) Cortical Bone, Chips (1-4 mm, 30 cc), Product #LCQSM;
y) Iliac Crest Wedge (18+ mm), Product #LIWXLM;
z) Cervical Allograft Segments (6x11x13mm), Product #CAS61113;
aa) Cervical Allograft Segments (5x11x13mm), Product #CAS51113;
bb) Cervical Allografts, 3000 series:
a) BS30-3005 (5mm);
b) BS30-3006 (6mm);
c) BS30-3007 (7mm);
d) BS30-3008 (8mm);
e) BS30-3009 (9mm);
f) BS30-3010 (10mm),
cc) Corticocancellous Allografts, 4000 series:
a) BS30-4005 (5mm);
b) BS30-4006 (6mm);
c) BS30-4007 (7mm);
d) BS30-4008 (8mm);
e) BS30-4009 (9mm);
f) BS30-4010 (10mm);
dd) Peroneus Longus, Product #LPLTM;
ee) Cancellous Cubes (croutons), 30 cc, Product #LCUMM;
ff) Ilium Bicortical Block, Product #LBBM,
gg) Cancellous Chips, 104mm (15 cc), Product #LCCPM,
CODE
a) Tissue ID#2004-010-006, 2004-013-005, 2004-013-006, 2004-014-006, 2004-015-003,
2004-015-004, 2004-016-003, 2004-017-003, 2004-017-004, 2004-021-005, 2004-021-006,
2004-023-005, 2004-023-006, 2004-024-005, 2004-024-006, 2004-026-003, 2004-026-004,
2004-031-001, 2004-031-002, 2004-032-005, 2004-032-006, 2004-034-003, 2004-035-005,
2004-035-006, 2004-036-003, 2004-036-004, 2004-037-002, 2004-039-005, 2004-040-004,
2004-041-005, 2004-041-006, 2004-043-001, 2004-043-002, 2004-046-003, 2004-047-001,
2004-047-002, 2004-067-002, 2004-070-003, 2004-079-003, 2004-079-004, 2004-080-003,
2004-080-004, 2004-084-003, 2004-087-005, 2004-088-003, 2004-088-004, 2005-001-006,
2005-002-067, 2005-003-023, 2005-003-024, 2005-005-001, 2005-005-002, 2005-007-050,
2005-009-011, 2005-028-002, 2005-031-001, 2005-031-002, 2005-032-006, 2005-297-002,
2005-353-004;
b) Tissue ID #2004-017-014, 2004-017-016, 2004-017-019, 2004-017-020, 2004-017-022,
2004-017-025, 2004-017-028, 2004-017-031, 2004-017-032, 2004-017-033, 2004-017-034,
2004-032-028, 2004-079-015, 2004-085-035, 2004-087-029, 2005-009-026, 2005-009-027,
2005-032-035, 2005-032-036, 2005-032-037, 2005-032-038, 2005-032-039;
c) Tissue ID#2004-036-021, 2004-068-018, 2004-078-039, 2005-002-084, 2005-002-085,
2005-004-109, 2005-031-038, 2005-031-039;
d) Tissue ID #2004-015-015, 2004-015-018, 2004-015-019, 2004-015-020, 2004-015-021,
2004-015-022, 2004-015-024, 2004-015-025;
e) Tissue ID #2004-013-007, 2004-013-008, 2004-015-009, 2004-016-004, 2004-017-005,
2004-017-006, 2004-018-001, 2004-018-002, 2004-021-007, 2004-021-008, 2005-030-024,
2005-031-010, 2005-035-008, 2005-353-007;
f) Tissue ID #2004-015-001, 2004-015-002, 2004-017-002, 2004-022-001, 2004-026-002,
2004-030-001, 2004-030-002, 2004-034-002, 2004-036-002, 2004-037-001, 2004-037-017,
2004-038-001, 2004-046-001, 2004-046-002, 2004-048-002, 2004-069-002, 2004-078-002,
2004-079-001, 2004-079-002, 2004-080-002, 2004-081-003, 2004-084-002, 2005-002-065,
2005-002-064, 2005-003-027, 2005-030-020, 2005-353-001, 2005-031-004;
g) Tissue ID #2004-084-001, 2004-086-001, 2004-086-002, 2004-086-004, 2004-087-004,
2005-001-001, 2005-001-004, 2005-003-025, 2005-004-008, 2005-004-009, 2005-007-048,
2005-008-002, 2005-028-006, 2005-029-042, 2005-029-044, 2005-029-045, 2005-085-003;
h) Tissue ID #2004-008-002, 2004-008-003, 2004-008-015, 2004-010-008, 2004-010-019,
2004-013-022, 2004-013-023, 2004-013-024, 2004-014-013, 2004-014-015, 2004-014-016,
2004-014-017, 2004-014-018, 2004-014-020, 2004-014-021, 2004-014-022, 2004-014-023,
2004-015-027, 2004-015-028, 2004-015-029, 2004-016-014, 2004-016-015, 2004-016-016,
2004-016-018, 2004-016-020, 2004-016-022, 2004-016-023, 2004-016-024, 2004-016-027,
2004-016-028, 2004-016-029, 2004-018-012, 2004-018-013, 2004-018-014, 2004-018-015,
2004-018-016, 2004-018-017, 2004-018-018, 2004-018-019, 2004-018-020, 2004-018-021,
2004-018-022, 2004-018-023, 2004-021-019, 2004-021-020, 2004-022-006, 2004-022-007,
2004-022-010, 2004-022-013, 2004-022-014, 2004-022-015, 2004-023-018, 2004-023-019,
2004-023-021, 2004-023-023, 2004-023-025, 2004-023-027, 2004-023-028, 2004-023-029,
2004-023-032, 2004-024-009, 2004-024-010, 2004-024-011, 2004-024-012, 2004-024-013,
2004-024-014, 2004-024-015, 2004-024-016, 2004-024-017, 2004-024-018, 2004-024-019,
2004-025-001, 2004-025-002, 2004-025-003, 2004-025-004, 2004-025-005, 2004-025-006,
2004-026-007, 2004-026-008, 2004-026-009, 2004-026-010, 2004-026-011, 2004-026-012,
2004-026-013, 2004-026-014, 2004-026-015, 2004-026-016, 2004-026-017, 2004-026-018,
2004-026-019, 2004-026-020, 2004-026-021, 2004-026-022, 2004-030-005, 2004-030-006,
2004-030-007, 2004-030-008, 2004-030-009, 2004-030-010, 2004-030-011, 2004-030-012,
2004-030-013, 2004-030-014, 2004-030-015, 2004-031-005, 2004-031-007, 2004-031-008,
2004-031-009, 2004-031-010, 2004-031-011, 2004-031-012, 2004-031-013, 2004-031-014,
2004-031-015, 2004-031-016, 2004-031-017, 2004-032-007, 2004-032-008, 2004-032-009,
2004-032-010, 2004-032-011, 2004-032-012, 2004-032-013, 2004-032-014, 2004-032-015,
2004-032-016, 2004-032-017, 2004-032-020, 2004-032-021, 2004-032-022, 2004-032-023,
2004-032-024, 2004-032-026, 2004-034-011, 2004-034-012, 2004-034-013, 2004-034-014,
2004-035-026, 2004-035-027, 2004-035-028, 2004-035-029, 2004-035-030, 2004-035-031,
2004-035-032, 2004-035-033, 2004-035-034, 2004-035-035, 2004-035-036, 2004-035-037,
2004-035-038, 2004-035-039, 2004-035-040, 2004-035-041, 2004-035-042, 2004-035-043,
2004-035-044, 2004-035-045, 2004-035-046, 2004-035-047, 2004-035-048, 2004-035-049,
2004-035-050, 2004-035-051, 2004-035-052, 2004-035-053, 2004-035-054, 2004-036-009,
2004-036-016, 2004-037-008, 2004-037-009, 2004-037-012, 2004-038-012, 2004-038-013,
2004-038-014, 2004-038-015, 2004-039-016, 2004-039-017, 2004-039-019, 2004-039-020,
2004-039-021, 2004-039-022, 2004-039-023, 2004-039-024, 2004-039-025, 2004-039-026,
2004-039-027, 2004-039-028, 2004-039-029, 2004-039-030, 2004-039-031, 2004-039-032,
2004-039-033, 2004-039-034, 2004-039-035, 2004-039-036, 2004-040-014, 2004-040-015,
2004-040-016, 2004-040-017, 2004-040-018, 2004-040-019, 2004-040-020, 2004-041-015,
2004-041-024, 2004-042-008, 2004-042-009, 2004-042-010, 2004-042-011, 2004-042-012,
2004-042-013, 2004-042-014, 2004-042-015, 2004-042-016, 2004-042-017, 2004-042-018,
2004-042-019, 2004-042-020, 2004-042-021, 2004-042-022, 2004-042-023, 2004-043-005,
2004-043-006, 2004-043-007, 2004-043-008, 2004-043-009, 2004-043-010, 2004-043-011,
2004-043-012, 2004-043-013, 2004-043-014, 2004-043-015, 2004-043-016, 2004-043-017,
2004-043-018, 2004-043-019, 2004-043-020, 2004-046-006, 2004-046-007, 2004-046-008,
2004-046-009, 2004-046-010, 2004-046-011, 2004-046-012, 2004-046-013, 2004-047-059,
2004-047-060, 2004-047-061, 2004-047-062, 2004-047-063, 2004-047-064, 2004-047-065,
2004-047-066, 2004-047-067, 2004-047-068, 2004-047-070, 2004-047-071, 2004-047-072,
2004-047-074, 2004-047-076, 2004-048-012, 2004-054-002, 2004-054-003, 2004-054-004,
2004-054-005, 2004-054-006, 2004-054-007, 2004-054-008, 2004-055-003, 2004-055-005,
2004-055-007, 2004-055-011, 2004-055-012, 2004-056-002, 2004-056-003, 2004-056-004,
2004-056-005, 2004-056-007, 2004-057-008, 2004-057-009, 2004-057-010, 2004-057-011,
2004-057-015, 2004-057-016, 2004-057-018, 2004-057-019, 2004-057-020, 2004-057-021,
2004-057-022, 2004-057-023, 2004-057-024, 2004-057-025, 2004-057-026, 2004-057-027,
2004-058-006, 2004-058-007, 2004-058-008, 2004-058-009, 2004-059-009, 2004-059-010,
2004-059-011, 2004-059-012, 2004-059-013, 2004-059-014, 2004-059-015, 2004-059-016,
2004-059-017, 2004-059-018, 2004-059-019, 2004-059-020, 2004-059-023, 2004-065-007,
2004-065-008, 2004-065-009, 2004-065-011, 2004-065-013, 2004-065-014, 2004-065-015,
2004-065-017, 2004-065-018, 2004-065-023, 2004-065-025, 2004-065-027, 2004-065-028,
2004-066-012, 2004-066-013, 2004-066-014, 2004-066-015, 2004-066-016, 2004-066-018,
2004-066-021, 2004-066-023, 2004-066-024, 2004-066-026, 2004-066-027, 2004-066-028,
2004-066-029, 2004-066-032, 2004-066-033, 2004-066-034, 2004-066-035, 2004-067-003,
2004-067-004, 2004-067-005, 2004-067-006, 2004-067-007, 2004-067-008, 2004-067-012,
2004-067-014, 2004-067-015, 2004-068-007, 2004-068-012, 2004-069-007, 2004-069-008,
2004-069-009, 2004-069-010, 2004-069-011, 2004-069-012, 2004-069-013, 2004-069-014,
2004-069-015, 2004-069-016, 2004-070-004, 2004-070-005, 2004-070-006, 2004-070-007,
2004-070-008, 2004-070-009, 2004-070-010, 2004-070-011, 2004-076-007, 2004-076-008,
2004-076-009, 2004-076-010, 2004-076-011, 2004-076-012, 2004-076-013, 2004-076-014,
2004-076-015, 2004-076-016, 2004-076-017, 2004-076-018, 2004-076-019, 2004-076-020,
2004-078-011, 2004-078-012, 2004-078-013, 2004-078-014, 2004-078-015, 2004-078-016,
2004-078-017, 2004-078-018, 2004-078-019, 2004-078-020, 2004-078-021, 2004-078-022,
2004-078-023, 2004-078-024, 2004-078-025, 2004-078-026, 2004-078-027, 2004-078-028,
2004-078-029, 2004-078-030, 2004-078-031, 2004-078-032, 2004-079-005, 2004-079-006,
2004-079-007, 2004-079-008, 2004-079-009, 2004-079-010, 2004-079-011, 2004-079-012,
2004-079-013, 2004-079-014, 2004-080-019, 2004-080-020, 2004-080-021, 2004-080-022,
2004-080-023, 2004-080-024, 2004-080-025, 2004-080-026, 2004-080-027, 2004-080-028,
2004-081-004, 2004-081-005, 2004-081-006, 2004-081-007, 2004-081-008, 2004-081-009,
2004-081-010, 2004-081-011, 2004-081-012, 2004-082-005, 2004-082-006, 2004-082-007,
2004-082-008, 2004-082-009, 2004-082-010, 2004-082-011, 2004-082-012, 2004-083-005,
2004-083-006, 2004-083-008, 2004-083-009, 2004-084-005, 2004-084-006, 2004-084-007,
2004-084-009, 2004-084-010, 2004-084-011, 2004-084-012, 2004-085-027, 2004-085-028,
2004-085-031, 2004-086-009, 2004-086-010, 2004-086-011, 2004-086-012, 2004-086-013,
2004-086-014, 2004-086-015, 2004-086-016, 2004-086-017, 2004-086-018, 2004-086-019,
2004-086-020, 2004-086-021, 2004-086-022, 2004-086-023, 2004-086-024, 2004-086-025,
2004-086-026, 2004-086-027, 2004-086-028, 2004-086-029, 2004-086-030, 2004-087-009,
2004-087-010, 2004-087-011, 2004-087-012, 2004-087-013, 2004-087-014, 2004-087-015,
2004-087-016, 2004-087-017, 2004-087-018, 2004-087-019, 2004-087-020, 2004-087-021,
2004-087-022, 2004-087-023, 2004-087-024, 2004-087-025, 2004-087-026, 2004-087-027,
2004-087-028, 2005-002-079, 2005-002-082, 2005-009-022, 2005-009-023, 2005-009-024,
2005-028-016, 2004-039-018;
i) Tissue ID #2004-008-019, 2004-008-020, 2004-010-026, 2004-010-027, 2004-013-035,
2004-013-036, 2004-014-031, 2004-014-032, 2004-015-034, 2004-015-035, 2004-021-017,
2004-021-018, 2004-022-004, 2004-023-008, 2004-031-003, 2004-031-004, 2004-032-034,
2004-036-008, 2004-040-005, 2004-040-006, 2004-041-007, 2004-041-008, 2004-043-003,
2004-043-004, 2004-047-004, 2004-055-001, 2004-078-010, 2004-085-015, 2004-085-016,
2004-086-007, 2005-001-018, 2005-002-074, 2005-007-061, 2004-065-005;
j) Tissue ID #2004-037-004 and 2004-037-005;
k) Tissue ID #2004-013-019, 2004-013-010, 2004-015-008, 2004-018-003, 2004-021-009,
2004-021-010, 2004-035-010, 2005-031-007
l) Tissue ID #2004-021-037, 2004-021-038, 2004-021-039, 2004-021-040, 2004-021-041,
2004-021-042, 2004-021-044, 2004-021-045, 2004-021-046, 2004-021-047, 2004-021-048,
2004-021-049, 2004-021-050, 2004-021-051, 2004-022-016, 2004-022-017, 2004-022-018,
2004-022-019, 2004-022-020, 2004-032-030, 2004-032-032, 2004-032-033, 2004-035-055,
2004-035-056, 2004-035-057, 2004-035-058, 2004-035-059, 2004-035-060, 2004-035-061,
2004-035-062, 2004-035-063, 2004-035-064, 2004-035-065, 2004-035-066, 2004-035-067,
2004-039-037, 2004-039-038, 2004-039-039, 2004-039-040, 2004-039-041, 2004-039-042,
2004-039-043, 2004-039-044, 2004-039-045, 2004-039-046, 2004-039-047;
m) Tissue ID #2004-013-013, 2004-013-014, 2004-013-015, 2004-013-016, 2004-014-007,
2004-014-008, 2004-015-010, 2004-015-011, 2004-015-012, 2004-016-008, 2004-016-009,
2004-016-010, 2004-016-011, 2004-017-007, 2004-017-008, 2004-017-009, 2004-017-010,
2004-018-007, 2004-018-008, 2004-018-009, 2004-018-010, 2004-021-013, 2004-021-014,
2004-021-015, 2004-035-011, 2004-035-012, 2004-035-014, 2004-036-006, 2004-047-003,
2004-078-005, 2004-078-006, 2004-078-007, 2004-078-008, 2004-080-011, 2004-088-007,
2005-001-013, 2005-001-014, 2005-001-015, 2005-002-071, 2005-002-072, 2005-002-073,
2005-003-028, 2005-003-029, 2005-003-030, 2005-004-019, 2005-004-020, 2004-005-012,
2005-005-013, 2005-006-010, 2005-007-057, 2005-007-058, 2005-007-059, 2005-007-060,
2005-008-007, 2005-008-008, 2005-009-017, 2005-028-013, 2005-028-014, 2005-030-030,
2005-030-031, 2005-297-007, 2005-297-008, 2005-297-009, 2005-297-010, 2005-353-008,
2005-353-009, 2005-353-010, 2005-353-011;
n) Tissue ID #2004-010-001, 2004-010-002, 2004-010-003, 2004-013-001, 2004-014-003,
2004-014-004, 2004-021-001, 2004-021-002, 2004-021-003, 2004-021-004, 2004-024-001,
2004-034-001, 2004-035-001, 2004-035-002, 2004-035-003, 2004-035-004, 2004-039-004,
2004-040-001, 2004-040-002, 2004-041-002, 2004-041-003, 2004-042-002, 2004-042-003,
2004-042-004, 2004-065-001, 2004-065-004, 2004-065-002, 2004-065-003;
o) Tissue ID #2005-004-108, 2004-085-043, 2004-085-044, 2004-085-045;
p) Tissue ID #2004-085-052, 2004-085-053, 2004-085-054, 2004-085-055, and 2004-087-037;
q) Tissue ID #2005-006-012, 2005-028-007, 2005-028-008;
r) Tissue ID #2004-014-025, 2004-014-028, 2004-031-048, 2004-034-015, 2004-034-016,
2004-048-014, 2004-059-029, 2004-065-029, 2004-066-043, 2004-068-017, 2005-008-081;
s) Tissue ID#2005-031-032, 2005-004-107;
t) Tissue ID #2004-042-084, 2004-042-085, 2005-007-067, 2005-007-068, 2004-088-009;
u) Tissue ID #2004-047-018, 2004-047-019;
v) Tissue ID #2004-034-020, 2004-034-021, 2004-034-022, 2004-034-023, 2004-034-024,
2004-034-025, 2004-034-026, 2004-034-027, 2004-034-028, 2004-034-030, 2004-034-033;
w) Tissue ID# 2004-021-057, 2004-021-058, 2004-021-059, 2004-021-062, 2004-022-026,
2004-030-018, 2004-031-020, 2004-031-024, 2004-034-017, 2004-035-074, 2004-035-075,
2004-035-076, 2004-035-077, 2004-036-022, 2004-036-024, 2004-036-025, 2004-039-049,
2004-039-050, 2004-039-051, 2004-039-052, 2004-047-083, 2004-048-015, 2004-057-034,
2004-058-020, 2004-066-048, 2004-068-019, 2004-068-021, 2004-068-023, 2004-078-042,
2004-078-043, 2004-078-044, 2004-078-045, 2004-086-035, 2004-086-037;
x) Tissue ID#2004-017-035, 2004-017-036, 2004-026-032, 2004-026-033, 2004-030-017,
2004-056-008, 2004-056-009, 2004-038-19, 2004-038-19, 2004-038-20;
y) Tissue ID#2004-021-060, 2004-021-061, 2004-022-024, 2004-023-036, 2004-023-037,
2004-031-021, 2004-031-022, 2004-034-018, 2004-039-053, 2004-043-021, 2004-043-022,
2004-080-016, 2004-080-017;
z) Tissue ID#2004-042-057;
aa) Tissue ID#2004-042-033;
bb) Cervical Allografts, 3000 series:
a) Tissue ID # 2004-021-063, 2004-021-066, 2005-004-111, 2005-007-073, 2005-008-083,
2005-008-084, 2005-008-085, 2005-008-086, 2005-008-087, 2005-008-088, 2005-008-090,
2005-008-091, 2005-029-067, 2005-029-068, 2005-029-070, 2005-029-071, 2005-029-072,
2005-029-073, 2005-029-074, 2005-029-075, 2005-029-076, 2005-029-077, 2005-029-078,
2005-029-079, 2005-029-080, 2005-029-081, 2005-029-082;
b) Tissue ID # 2004-021-067, 2004-021-068, 2004-021-071, 2005-004-113, 2005-007-076,
2005-008-092, 2005-008-093, 2005-008-094, 2005-008-095, 2005-008-096, 2005-008-097,
2005-008-098, 2005-029-083, 2005-029-084, 2005-029-085, 2005-029-088, 2005-029-090,
2005-029-091, 2005-029-092, 2005-029-093, 2005-029-094, 2005-029-095;
c) Tissue ID # 2004-021-074, 2005-004-116, 2005-008-102, 2005-008-103, 2005-008-106,
2005-008-107, 2005-008-108, 2005-008-109, 2005-008-110, 2005-008-111, 2005-029-096,
2005-029-097, 2005-029-098, 2005-029-100, 2005-029-101;
d) Tissue ID # 2004-013-065, 2004-013-067, 2004-021-075, 2005-004-120, 2005-004-121,
2005-008-112, 2005-008-113, 2005-008-114, 2005-008-116, 2005-008-117, 2005-029-102,
2005-029-103, 2005-031-090, 2005-031-091, 2005-031-092, 2005-031-093, 2005-031-094;
e) Tissue ID # 2004-013-068, 2004-013-070, 2004-013-071, 2004-013-074, 2004-013-075,
2004-013-078, 2004-013-079, 2004-013-083, 2004-013-085, 2004-013-086, 2004-021-076,
2004-021-077, 2004-021-078, 2004-021-079, 2004-021-081, 2004-021-082, 2004-021-083,
2005-004-122, 2005-004-123, 2005-004-124, 2005-004-127, 2005-004-128, 2005-004-129,
2005-004-130, 2005-004-131, 2005-004-132, 2005-004-135, 2005-004-137, 2005-004-139,
2005-004-140, 2005-004-141, 2005-004-142, 2005-004-143, 2005-008-119, 2005-008-120,
2005-029-106, 2005-029-109, 2005-029-110, 2005-029-112, 2005-029-113, 2005-029-114,
2005-031-095, 2005-031-096, 2005-031-097, 2005-031-100, 2005-031-102, 2005-031-104,
2005-031-105, 2005-031-106, 2005-031-107, 2005-031-108;
f) Tissue ID # 2004-013-088, 2004-013-090, 2004-013-092, 2004-013-093, 2004-013-094,
2005-008-121, 2005-008-122, 2005-008-123, 2005-008-124, 2005-029-115, 2005-029-116,
2005-029-117, 2005-029-118, 2005-029-119, 2005-029-120, 2005-029-121, 2005-031-110,
2005-031-111, 2005-031-114, 2005-031-115, 2005-031-119, 2005-031-120, 2005-031-121,
2005-031-122, 2005-031-124, 2005-031-126, 2005-031-128, 2005-031-129, 2005-031-130,
2005-031-131, 2005-031-132;
cc) Corticocancellous Allografts, 4000 series:
a) Tissue ID # 2004-014-033, 2004-042-087, 2004-042-088, 2004-042-089, 2004-042-090,
2004-083-013, 2004-083-014, 2004-083-015, 2004-087-039, 2004-087-040, 2004-087-041,
2004-087-042, 2005-001-019, 2005-001-020, 2005-002-002, 2005-004-021, 2005-004-022,
2005-004-023, 2005-004-024, 2005-004-025, 2005-004-026, 2005-004-027, 2005-004-028,
2005-004-029, 2005-006-021, 2005-006-022, 2005-007-001, 2005-007-002, 2005-008-019,
2005-008-020, 2005-008-021, 2005-008-022, 2005-008-023, 2005-028-026, 2005-028-027,
2005-029-001, 2005-029-002, 2005-031-054, 2005-031-055, 2005-031-056, 2005-031-057,
2005-032-009, 2005-032-010, 2005-032-011, 2005-032-012, 2005-032-013, 2005-032-014,
2005-032-015;
b) Tissue ID # 2004-014-034, 2004-014-035, 2004-014-036, 2004-014-037, 2004-024-023,
2004-024-024, 2004-024-025, 2004-024-026, 2004-024-027, 2004-040-035, 2004-042-091,
2004-042-092, 2004-042-093, 2004-042-094, 2004-046-004, 2004-083-016, 2004-085-056,
2004-087-043, 2004-087-044, 2004-087-045, 2004-087-046, 2005-001-021, 2005-001-022,
2005-001-023, 2005-001-024, 2005-002-003, 2005-002-004, 2005-002-005, 2005-002-006,
2005-002-007, 2005-002-008, 2005-004-030, 2005-004-031, 2005-004-032, 2005-004-033,
2005-004-034, 2005-004-035, 2005-004-036, 2005-004-037, 2005-004-038, 2005-004-039,
2005-004-040, 2005-004-041, 2005-004-042, 2005-004-043, 2005-005-019, 2005-006-023,
2005-007-003, 2005-007-004, 2005-007-005, 2005-007-006, 2005-007-007, 2005-008-024,
2005-008-025, 2005-008-026, 2005-008-027, 2005-008-028, 2005-008-029, 2005-008-030,
2005-008-031, 2005-008-032, 2005-008-033, 2005-008-034, 2005-009-001, 2005-009-002,
2005-009-003, 2005-009-019, 2005-009-020, 2005-009-021, 2005-028-028, 2005-028-029,
2005-028-030, 2005-028-031, 2005-029-003, 2005-029-004, 2005-029-005, 2005-030-001,
2005-030-002, 2005-031-058, 2005-031-059, 2005-031-060, 2005-031-061, 2005-031-062,
2005-031-063, 2005-031-064, 2005-031-065, 2005-031-066, 2005-031-067, 2005-032-016,
2005-032-018, 2005-032-019, 2005-032-020, 2005-032-021, 2005-032-022, 2005-032-023,
2005-032-024, 2005-032-025, 2005-032-026, 2005-032-027, 2005-297-013, 2005-297-014,
2005-353-012;
c) Tissue ID # 2004-013-038, 2004-013-039, 2004-013-040, 2004-013-041, 2004-013-042,
2004-013-043, 2004-013-044, 2004-013-045, 2004-013-046, 2004-013-047, 2004-013-048,
2004-014-038, 2004-014-039, 2004-014-040, 2004-014-041, 2004-014-042, 2004-014-043,
2004-014-044, 2004-014-045, 2004-014-046, 2004-014-047, 2004-014-048, 2004-014-049,
2004-024-028, 2004-024-029, 2004-024-030, 2004-024-031, 2004-040-036, 2004-042-095,
2004-046-004-002, 2004-083-017, 2004-083-018, 2004-083-019, 2004-083-020, 2004-083-021,
2004-085-057, 2004-085-058, 2004-087-047, 2004-087-048, 2005-001-025, 2005-001-026,
2005-001-027, 2005-002-009, 2005-002-010, 2005-002-011, 2005-002-012, 2005-002-013,
2005-002-014, 2005-002-015, 2005-002-016, 2005-002-017, 2005-002-018, 2005-002-019,
2005-002-020, 2005-002-021, 2005-002-022, 2005-002-023, 2005-002-024, 2005-003-003,
2005-003-004, 2005-004-044, 2005-004-045, 2005-004-046, 2005-004-047, 2005-004-048,
2005-004-049, 2005-004-050, 2005-004-051, 2005-004-052, 2005-004-053, 2005-004-054,
2005-004-055, 2005-004-056, 2005-004-057, 2005-004-058, 2005-004-059, 2005-004-060,
2005-005-020, 2005-005-021, 2005-005-022, 2005-005-023, 2005-006-024, 2005-006-026,
2005-007-008, 2005-007-009, 2005-007-010, 2005-007-011, 2005-007-012, 2005-007-013,
2005-007-014, 2005-007-015, 2005-007-016, 2005-007-017, 2005-007-018, 2005-007-019,
2005-007-020, 2005-007-021, 2005-007-022, 2005-007-023, 2005-007-024, 2005-007-025,
2005-008-035, 2005-008-036, 2005-008-037, 2005-008-038, 2005-008-039, 2005-008-040,
2005-008-041, 2005-008-042, 2005-008-043, 2005-008-044, 2005-008-045, 2005-008-046,
2005-009-004, 2005-009-005, 2005-009-006, 2005-009-007, 2005-009-018, 2005-028-032,
2005-028-033, 2005-028-034, 2005-028-035, 2005-028-036, 2005-028-037, 2005-028-038,
2005-028-040, 2005-029-006, 2005-029-007, 2005-029-008, 2005-029-009, 2005-029-010,
2005-029-011, 2005-029-012, 2005-029-014, 2005-029-015, 2005-029-016, 2005-029-017,
2005-029-018, 2005-030-003, 2005-030-004, 2005-030-005, 2005-030-006, 2005-030-007,
2005-030-008, 2005-030-009, 2005-031-068, 2005-031-069, 2005-031-070, 2005-031-071,
2005-031-072, 2005-032-029, 2005-032-030, 2005-032-031, 2005-032-032, 2005-032-033,
2005-297-015, 2005-297-019;
d) Tissue ID # 2004-013-049, 2004-013-050, 2004-013-051, 2004-013-052, 2004-013-053,
2004-013-054, 2004-013-055, 2004-013-056, 2004-013-057, 2004-013-058, 2004-013-059,
2004-014-050, 2004-014-051, 2004-014-052, 2004-014-053, 2004-014-054, 2004-014-055,
2004-014-056, 2004-014-057, 2004-014-058, 2004-014-059, 2004-024-032, 2004-024-033,
2004-024-034, 2004-024-035, 2004-040-037, 2004-040-038, 2004-042-096, 2004-042-097,
2004-042-098, 2004-042-099, 2004-046-004-003, 2004-046-005-001, 2004-085-059, 2004-087-049,
2004-087-050, 2005-001-028, 2005-001-029, 2005-001-031, 2005-002-025, 2005-002-026,
2005-002-027, 2005-002-028, 2005-002-029, 2005-002-030, 2005-002-031, 2005-002-032,
2005-002-033, 2005-002-034, 2005-002-035, 2005-002-036, 2005-002-037, 2005-002-038,
2005-002-039, 2005-002-040, 2005-002-041, 2005-002-042, 2005-002-043, 2005-002-044,
2005-002-045, 2005-002-046, 2005-002-047, 2005-002-048, 2005-002-049, 2005-002-050,
2005-003-005, 2005-003-006, 2005-003-009, 2005-003-010, 2005-003-011, 2005-003-012,
2005-004-061, 2005-004-062, 2005-004-063, 2005-004-064, 2005-004-065, 2005-004-066,
2005-004-067, 2005-004-068, 2005-004-069, 2005-004-070, 2005-004-071, 2005-004-072,
2005-004-073, 2005-004-074, 2005-004-075, 2005-004-076, 2005-004-077, 2005-004-078,
2005-005-024, 2005-005-025, 2005-005-026, 2005-005-027, 2005-005-028, 2005-005-029,
2005-007-026, 2005-007-027, 2005-007-028, 2005-007-029, 2005-007-030, 2005-007-031,
2005-007-032, 2005-007-033, 2005-007-034, 2005-007-035, 2005-007-036, 2005-007-037,
2005-007-038, 2005-007-039, 2005-007-040, 2005-007-042, 2005-008-047, 2005-008-048,
2005-008-049, 2005-008-050, 2005-008-051, 2005-008-052, 2005-009-008, 2005-009-009,
2005-028-042, 2005-028-044, 2005-028-045, 2005-028-046, 2005-028-047, 2005-029-019,
2005-029-020, 2005-029-021, 2005-029-022, 2005-029-023, 2005-029-024, 2005-029-025,
2005-029-026, 2005-029-027, 2005-029-028, 2005-029-029, 2005-030-010, 2005-030-011,
2005-030-012, 2005-030-013, 2005-030-014, 2005-030-015, 2005-030-016, 2005-031-073,
2005-031-074, 2005-031-075, 2005-031-076, 2005-031-077, 2005-032-034, 2005-297-020,
2005-297-022, 2005-297-023, 2005-297-024, 2005-353-013, 2005-353-014, 2005-353-016;
e) Tissue ID # 2004-013-060, 2004-013-061, 2004-013-062, 2004-013-063, 2004-013-064,
2004-014-060, 2004-014-061, 2004-014-062, 2004-014-063, 2004-014-064, 2004-024-036,
2004-024-037, 2004-024-038, 2004-024-039, 2004-040-039, 2004-042-100, 2004-042-101,
2004-042-102, 2004-042-103, 2004-046-005-002, 2004-046-005-003, 2004-083-022, 2004-085-061,
2005-002-051, 2005-002-052, 2005-002-053, 2005-002-054, 2005-002-055, 2005-002-056,
2005-002-057, 2005-002-058, 2005-002-059, 2005-002-060, 2005-002-061, 2005-002-062,
2005-003-020, 2005-003-022, 2005-004-079, 2005-004-080, 2005-004-081, 2005-004-082,
2005-004-083, 2005-004-084, 2005-004-085, 2005-004-086, 2005-004-087, 2005-004-088,
2005-004-089, 2005-005-030, 2005-005-031, 2005-005-032, 2005-005-033, 2005-005-034,
2005-005-035, 2005-005-036, 2005-005-037, 2005-005-038, 2005-005-039, 2005-005-042,
2005-006-033, 2005-006-034, 2005-006-035, 2005-006-036, 2005-006-037, 2005-007-043,
2005-007-044, 2005-008-053, 2005-008-054, 2005-008-055, 2005-008-056, 2005-008-057,
2005-008-058, 2005-008-059, 2005-008-060, 2005-008-061, 2005-008-062, 2005-008-063,
2005-028-048, 2005-029-031, 2005-029-032, 2005-029-033, 2005-029-034, 2005-029-035,
2005-029-036, 2005-029-037, 2005-029-038, 2005-029-039, 2005-029-040, 2005-029-041,
2005-030-017, 2005-030-018, 2005-031-078, 2005-031-079, 2005-031-080, 2005-031-081,
2005-031-082, 2005-297-025, 2005-297-026, 2005-353-017, 2005-353-018;
f) Tissue ID # 2004-014-065, 2004-014-066, 2004-024-041, 2004-040-043, 2004-040-044,
2004-040-045, 2004-040-046, 2004-040-047, 2004-040-048, 2004-040-049, 2004-042-104,
2004-042-105, 2004-042-106, 2004-087-051, 2005-001-039, 2005-001-040, 2005-001-041,
2005-001-042, 2005-001-043, 2005-001-044, 2005-001-045, 2005-002-063, 2005-004-090,
2005-004-091, 2005-004-092, 2005-004-093, 2005-004-094, 2005-004-095, 2005-004-096,
2005-004-097, 2005-004-098, 2005-004-099, 2005-004-100, 2005-005-043, 2005-008-064,
2005-008-065, 2005-008-066, 2005-008-067, 2005-008-068, 2005-008-069, 2005-008-070,
2005-008-071, 2005-008-072, 2005-008-073, 2005-028-053, 2005-031-083, 2005-031-084,
2005-031-085, 2005-031-086, 2005-031-087, 2005-031-088, 2005-297-029, 2005-297-033,
2005-297-034, 2005-297-035, 2005-297-036, 2005-353-020;
g) Tissue ID#2004-013-011;
h) Tissue ID#2004-048-005, 2004-048-008, 2004-088-010, 2004-088-012, 2004-088-013,
2004-088-014;
i) Tissue ID #2004-035-073;
j) Tissue ID #2005-297-045 and 2005-353-024
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lost Mountain Tissue Bank, Kennesaw, GA, by voluntary withdrawal notification dated July 10, 2006 and a written notification dated September 5, 2006.
Manufacturer: Donor Referral Services, Raleigh, NC. Firm initiated recall is ongoing.
REASON
Human tissues, recovered from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,742 allografts
DISTRIBUTION
Nationwide, Turkey and Korea

snip...

___________________________________


PRODUCT
Human Tissue for Transplantation: Corneas, Recall # B-0754-07
CODE
Tissue numbers: 060028100(OD) and 060028200
RECALLING FIRM/MANUFACTURER
Oklahoma Lions Eye Bank, Oklahoma City, OK, by telephone on July 19, 2006 and by letter on July 31, 2006. Firm initiated recall is complete.
REASON
Human Corneas, inadequately tested for infectious diseases in that the blood sample used for testing may have been hemodiluted, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
OK and CA

___________________________________

snip...

END OF ENFORCEMENT REPORT FOR FEBRUARY 21, 2007

###

http://www.fda.gov/bbs/topics/enforce/2007/ENF00992.html

[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)


http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf

THE SEVEN SCIENTIST REPORT ***


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf


PAUL BROWN M.D.

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf


9 December 2005
Division of Dockets Management (RFA-305)

SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf

Embassy of Japan
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm

Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of
Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm


03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf


03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf


Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket
No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al
[Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and
...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf


In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:
732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...

http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf


Volume 12, Number 12–December 2006


PERSPECTIVE

On the Question of Sporadic

or Atypical Bovine SpongiformEncephalopathy and

Creutzfeldt-Jakob Disease

Paul Brown,* Lisa M. McShane,† Gianluigi Zanusso,‡ and Linda Detwiler§

Strategies to investigate the possible existence of sporadic

bovine spongiform encephalopathy (BSE) require

systematic testing programs to identify cases in countries

considered to have little or no risk for orally acquired disease,

or to detect a stable occurrence of atypical cases in

countries in which orally acquired disease is disappearing.

To achieve 95% statistical confidence that the prevalence

of sporadic BSE is no greater than 1 per million (i.e., the

annual incidence of sporadic Creutzfeldt-Jakob disease

[CJD] in humans) would require negative tests in 3 million

randomly selected older cattle. A link between BSE and

sporadic CJD has been suggested on the basis of laboratory

studies but is unsupported by epidemiologic observation.

Such a link might yet be established by the discovery

of a specific molecular marker or of particular combinations

of trends over time of typical and atypical BSE and various

subtypes of sporadic CJD, as their numbers are influenced

by a continuation of current public health measures that

exclude high-risk bovine tissues from the animal and

human food chains.


SNIP...


http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm?s_cid=eid06_0965_e

disturbing to say the least. ...TSS






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