Vaccines, Blood & Biologics

2009 Biologics Recalls

Date
Notification
Brand Name Product Description Reason/Problem Company
12/22/2009 Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Lots 500754P, 500756P, 500757P, 500758P, 500759P, 500760P, 500761P and 500762P May expire before their labeled expiration dates and are being recalled as a precautionary measure. MedImmune LLC
Philadelphia, PA
12/21/2009 T.R.U.E. Test Box T.R.U.E. Test Foil Panel Lot #: 94009
Lot #’s: (Panel 1.1-A94195, Panel 2.1-B94009, Panel 3.1-C94009)
Lot may contain an Ethylenediamine dihydrochloride patch #11 (Panel 1.1) that contains less than the labeled dose (0.018 mg of ethylenediamine per patch). Mekos Laboratories
Herredsvejen 2, Denmark

12/16/2009 Influenza A (H1N1) 2009 Monovalent Vaccine, Lots UT023DA, UT028CB, UT028DA, UT030CA Are intended for children 6 through 35 months of age Sanofi Pasteur
Swiftwater, Pennsylvania
10/27/2009 COBAS ® AmpliPrep/ COBAS ® AMPLICOR HIV-1 MONITOR Test Catalog Number: 03309401018
Lot Number: M08154
The QS copy number was incorrectly designated as 107 copies/PCR instead of 97 copies/PCR. Roche Diagnostics Corporation
Indianapolis, Indiana
7/10/2009 Prevnar pneumococcal 7-valent Conjugate Vaccine
(Diptheria CRM197Protein)
0.5 mL single dose pre-filled syring (10 per package)
NDC: 0005-1970-50 (10’s)/0005-1970-49 (Singles)

Lot Number: D50002

Which was not intended for commercial use, was inadvertently packaged and distributed with commercial product under Lot D50002. Wyeth
Philadelphia, PA
5/22/2009 Donor Management System (DMS) Blood Management Computer System Model Numbers:
DMS Versions 1.7.1, 1.8.0, 1.8.1, 1.9.0 1.9.1
When a user follows an unusual sequence of actions, it is possible to cause the wrong donor unit number to be saved on a donor visit record. Haemonetics
Software Solution Division
Edmonton, AB, Canada
4/10/2009 Haemonetics List No. 620 PCS2 Plasma Harness Set Lot Numbers:
081219511
081219512
081222510
081222511
081223510
081223511
081224510
081224511
081224512
Investigation has determined that a small number of Harness Sets within the affected lot numbers may have the potential to exhibit leaks at the filter cap assembly. Haemonetics Corporation
Braintree, Massachusetts
3/11/2009 Cerner HNA Classic PathNet Blood Bank Donor Versions 306 and 015 Where donor infectious disease testing interpretations and overall donor interpretation results may be performed using results from previous units with the same laboratory number. Cerner Corporation
Kansas City, Missouri
2/26/2009 Biotest Tango Automated Blood Bank Analyzer, Biotest AG-Dreieich Antibody Screen Wash with De-ionized Water, Software Version 3.1 Antibody screen testing may be washed using de-ionized water (System Liquid) instead of the intended Phosphate Buffered Saline (PBS, Wash Solution). Biotest AG-Dreieich
Dreieich, Germany
2/12/2009 Package Insert Update for MLB2 Modified LISS Solution Package Insert Number 187734 Version 06
Product Number: 805 200 100
An ambiguous statement in their package insert which incorrectly stated the centrifugation parameter Biotest AG - Dreiech
Dreieich, Germany
2/4/2009 FLUVIRIN (Influenza Virus Vaccine) Luer-Lok pre-filled syringes Lot Numbers: 878771P, 878772P, 878773P, 878775P, 878776P Routine stability testing of FLUVIRIN in prefilled Luer-Lok syringes revealed a minor deviation in the potency of the A/Brisbane (H1N1) component of the vaccine. Novartis Vaccines and Diagnostics Limited
Liverpool United Kingdom

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