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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2009 Biologics Recalls

Date NotificationBrand NameProduct DescriptionReason/ProblemCompany
12/22/2009Influenza A (H1N1) 2009 Monovalent Vaccine Live, IntranasalLots 500754P, 500756P, 500757P, 500758P, 500759P, 500760P, 500761P and 500762PMay expire before their labeled expiration dates and are being recalled as a precautionary measure.MedImmune LLC
Philadelphia, PA
12/21/2009T.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

12/16/2009Influenza A (H1N1) 2009 Monovalent Vaccine,Lots UT023DA, UT028CB, UT028DA, UT030CAAre intended for children 6 through 35 months of ageSanofi Pasteur
Swiftwater, Pennsylvania
10/27/2009COBAS ® AmpliPrep/ COBAS ® AMPLICOR HIV-1 MONITOR TestCatalog 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

7/10/2009Prevnar 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

5/22/2009Donor 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
4/10/2009Haemonetics List No. 620 PCS2 Plasma Harness SetLot 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
3/11/2009Cerner HNA Classic PathNet Blood Bank DonorVersions 306 and 015Where 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
2/26/2009Biotest Tango Automated Blood Bank Analyzer, Biotest AG-DreieichAntibody Screen Wash with De-ionized Water, Software Version 3.1Antibody 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
2/12/2009Package Insert Update for MLB2 Modified LISS SolutionPackage Insert Number 187734 Version 06
Product Number: 805 200 100
An ambiguous statement in their package insert which incorrectly stated the centrifugation parameterBiotest AG - Dreiech
Dreieich, Germany
2/4/2009FLUVIRIN (Influenza Virus Vaccine) Luer-Lok pre-filled syringesLot Numbers: 878771P, 878772P, 878773P, 878775P, 878776PRoutine 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