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From: TSS ()
Subject: Re: SEAC EVALUATION CRITERIA FOR ANTE MORTEM DIAGNOSTIC TESTS FOR SUBCLINICAL vCJD POSITION STATEMENT
Date: November 8, 2006 at 9:13 am PST
In Reply to: SEAC EVALUATION CRITERIA FOR ANTE MORTEM DIAGNOSTIC TESTS FOR SUBCLINICAL vCJD POSITION STATEMENT posted by TSS on November 7, 2006 at 9:38 am:
PRODUCT
Source Plasma, Recall # B-0160-7
CODE
Units: 68664169, 68650124, 68648299, 68643454
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 20, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
______________________________
PRODUCT
Source Plasma, Recall # B-0161-7
CODE
Units: 68621933, 68620080
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 21, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA ______________________________
PRODUCT
Source Plasma, Recall # B-0162-7
CODE
Units: 68668877, 68664350, 68633875
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 20, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA ______________________________
PRODUCT
Source Plasma, Recall # B-0163-7
CODE
Units: 68686871, 68683238, 68678425, 68674861, 68671037, 68665203, 68660994, 68658397, 68654276, 68650179, 68645830, 68639686, 68636920, 68621971, 68624392
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 21, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CA ______________________________
PRODUCT
Source Plasma, Recall # B-0164-7
CODE
Units: 68684402, 68681876, 68679446, 68674588, 68671976, 68667474, 68665135
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 19, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA ______________________________
PRODUCT
Source Plasma, Recall # B-0165-7
CODE
Unit: 68676056
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 19, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA ______________________________
PRODUCT
Source Plasma, Recall # B-0166-7
CODE
Units: 68648121, 68645663, 68641207, 68638559, 68625207, 68621063, 68618322, 68613846, 68611279
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 20, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA ______________________________
PRODUCT
Source Plasma, Recall # B-0167-7
CODE
Units: 02HWVA6493, 02HWVA7104, 02HWVA7567, 02HWVA8654, 02HWVA8902, 02HWVA9129, 02HWVA9494, 02HWVA9745
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services, L.P., Deerfield, IL, by facsimile on April 5, 2004.
Manufacturing Firm: BioLife Plasma Services, L.P., Huntington, WV. Firm initiated Recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
NC ______________________________ PRODUCT
Source Plasma, Recall # B-0252-7
CODE
Units: 68685676, 68679545, 68675752, 68672041
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 20, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA ______________________________
END OF ENFORCEMENT REPORT FOR November 8, 2006
### http://www.fda.gov/bbs/topics/enforce/2006/ENF00977.html
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