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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2013 Biologics Recalls

Date  NotificationBrand NameProduct DescriptionReason/Problem Company
4/26/2013Catalog Number: 81000
Serial Numbers: All		Terumo BCT is voluntarily recalling the Trima Accel system for the addition of a safety enhancement called Air Reduction Mitigation (ARM).Terumo BCT, Inc.
Lakewood, Colorado
4/24/2013Product Code 4R1584
Lot Number:  FM13A15027		Fenwal has initiated a voluntary Urgent Product Recall of one lot (FM13A15027) of product code 4R1584, Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK unit.Fenwal
Lake Zurich, IL
 
4/18/2013
Product Code Z451U
Lot Number V133096
After shipment, it was discovered that there was a mistake in the antigen profile prepared and shipped with ALBAcyte Antibody Screening Cells, product code Z451U, lot number V133096, expiring on May 20, 2013.
Quotient Biodiagnostics Inc.
Newtown, Pennsylvania
4/9/2013Catalog Number 808052100
Lot #8136070-01, Expiration Date August 29, 2013
Lot # 8203120-01, Expiration Date January 9, 2014		Bio-Rad Laboratories is notifying customers that ongoing stability testing of Seraclone Anti-S product has shown a decreased reactivity in lot numbers 8136070-01 and 8203120-01.Bio-Rad Laboratories, Inc.
Redmond, Washington
4/2/2013Urgent – Drug Recall - BIVIGAM Immune Globulin Intravenous (Human),10% Liquid, 100 mL sterile vialLot # 120016
Expiration Date: March 31, 2014		During a routine annual reserve inspection, visible particles were observed in the above lot number of BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid.Biotest Pharmaceuticals Corporation
Boca Raton, FL
3/1/2013Urgent Field Safety Notice (10699578) OpenGene DNA Sequencing System MicroCel 500 and MicroCel 300 Buffer Chamber Possible Hazard

MicroCel 500 buffer chamber
Part Number 10312319/VG 42115
Manufacture Date Code Range:  Dec-03-09-xx to Aug-02-10-xx

 

MicroCel 300 buffer chamber
Part Number 10319937/ VG 42044
Manufacture Date Code Range:  Feb-02-10-xx to Jul-07-10-xx

Some of these buffer chambers may have the potential to leak buffer when in use.Siemens Healthcare Diagnostics, Inc.
Berkeley, CA
2/21/2013Urgent Medical Device Recall / Field Safety Notice - Micro SSP DNA Typing TraysMultiple Identification Numbers Null allele information on the lot specific documents for these products is incorrect and may cause a mis-assignment.One Lambda, Inc.
Canoga Park, CA
2/7/2013Update To Urgent Product Correction Notification - Incomplete Foil Seal on Specific Lots of MTS™ Anti-IgG CardsMTS084024Ortho-Clinical Diagnostics, Inc. (OCD) issued a follow up to a previous Urgent Product Correction Notification dated November 5, 2012 regarding complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards. Micro Typing Systems
Pompano Beach, FL
2/1/2013Update To Urgent Product Correction Notification Incomplete Foil Seal on Specific Lots of MTS A/B/D Monoclonal and Reverse Grouping Card MTS080515Ortho-Clinical Diagnostics, Inc. (OCD) issued a follow up to a previous Urgent Product Correction Notification dated November 5, 2012 regarding complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards.Micro Typing Systems
Pompano Beach, FL
 

 

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