Vaccines, Blood & Biologics
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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 |
| 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) 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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