Vaccines, Blood & Biologics

2004 Biologics Recalls

Date
Notification
Brand NameProduct DescriptionReason/ProblemCompany
12/17/2004Recall of Leukocyte Reduction BPF4 High Efficiency Filter- Pall Medical CorpLOT NUMBERS:
Product Code 430-41
0450481
0450520
0450560
0450583
0450613
0450630
0450650
0450672
0450673
0450674
0450684
0450685
0450690
0450707
0450708
0450712
0490006

 


Product Code 430-50

0450574
0450626
0450661
0450665
0450668
0450710
0450714
Product Code BPFB
0450615
Pall Medical has received reports of hemolysis in the attached segment tubing and the storage bags observed at varying times following filtration using this product.Pall Medical Corporation
2200 Northern Blvd
East Hills, NY 11548
10/18-26/2004Notice of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection Systems Update-Haemonetics CorpAutomated Blood Cell Separator, Haemonetics Mobile Collection Systems
MCS+ 9000
MCS+ 7000
MCS+ 8100

Model Numbers
LN 09000-110-E
LN 07000-110-E
LN 08100-110-E

Haemonetics is aware of the possibility when using an MCS machine that a small leak at the base of the Latham bowl may cause the collection of blood from a donor to exceed the recommended extracorporeal volume limit.Haemonetics Corporation
Braintree, Massachusetts
10/18-26/2004Notice of Field Correction: Automated Blood Cell Separator, Haemonetics LN9000 Mobile Collection System-Haemontics CorpAutomated Blood Cell Separator, Haemonetics LN9000 Mobile Collection System
MCS+ 9000
Model Number: LN09000-110-E
Haemonetics is aware of the possibility when using an MCS machine that a small leak at the base of the Latham bowl may cause the collection of blood from a donor to exceed the recommended extracorporeal volume limit.Haemonetics Corporation
Braintree, Massachusetts
9/20/2004Recall of ORTHO Antibody to HBsAg ELISA Test System 3-Ortho Clinical DiagnosticsLOT NUMBER / EXPIRATION DATE :
HBK133 12/17/2004
Ortho-Clinical Diagnostics, Inc. has confirmed complaints of positive control failures when using ORTHO Antibody to HBsAg ELISA Test System 3.Ortho Clinical Diagnostics
Raritan, New Jersey
8/16/2004Recall of Trima Accel LRS Tubing Sets-Gambro BCT, IncCatalog Numbers:
777800-400 Trima Accel LRS Platelet, Plasma, RBC Set
777800-450 Trima Accel LRS Platelet, Plasma, RBC and TLR Filter Set

LOT NUMBER / EXPIRATION DATE :
05KXXXX 5/2006
06KXXXX 6/2006

Gambro BCT recently began to receive an increased number of reports of significantly lower yields/concentrations on platelet products that were collected on the Trima Accel Automated Blood Collection System.Gambro BCT, Inc.
Lakewood, Colorado
7/21/2004Recall of Amicus Separator Apheresis Device-Baxter Healthcare CorpAmicus Separator apheresis device, product codes 4R4580 and 4R4580R, installed with software version 2.51

 

Baxter Healthcare Corporation received four user reports that the Amicus Separator collected more plasma in the course of an apheresis procedure than desired or collected plasma when none was targeted.Baxter Healthcare Corporation
Round Lake, IL 60073
7/14/2004Recall of Limulus Amebocyte Lysate (LAL), Pyrotell-Associates of Cape Cod, IncLOT NUMBER / EXPIRATION DATE :
201-07-211
7/19/2006
Internal testing by Associates of Cape Cod, Inc. discovered that one lot of Pyrotell (2mL/vial, Lot # 201-07-211) showed moisture content slightly above specification.

 

Associates of Cape Cod, Inc.
Falmouth, MA
6/24/2004Recall of Amplicor HIV-1 Monitor Test, v 1.5-Roche Molecular Systems, IncAmplicor [3] AV-HRP Avidin-HRP (Horseradish Peroxidase) BGG Conjugate, Lot No. E09569, found in kit Lot No. E11360, Material No. 21118560018, expiration January, 2005
Amplicor [3] AV-HRP Avidin-HRP (Horseradish Peroxidase)BGG Conjugate, Lot No. E09569, found in kit Lot No. E11231, Material No. 21117750123, expiration September, 2004
NOTE:This product was only distributed to foreign consignees.

 

Roche has confirmed increased frequency of occurrence of "blue foci" with the Avidin-Horseradish Peroxidase (AV-HRP) Conjugate Lot E09659.Roche Molecular Systems, Inc
Belleville, New Jersey
6/24/2004Market Withdrawal of Immune Globulin Intravenous (Human), GAMMAGARD S/D, 10 gm-Baxter SALOT NUMBER / EXPIRATION DATE:
LE08D030AA 3/30/2006
There has been an increased frequency of adverse event reports of allergic reactions associated with this lot.Baxter SA
Lessines, Belgium
5/17/2004Recall of NucliSens Automated Isolation Reagents for Use with NucliSens HIV-1 QT - bioMerieux bvLOT NUMBER:
04031904
Some irregularities have been observed with one lot of this raw material, which may affect the sensitivity and accuracy of assays, such as the NucliSens HIV QT.bioMerieux bv
Boxtel, Netherlands
5/13/2004Medical Device Notification: HIV-1/HIV-2 Plus O EIA Testing Software-DiaSporin, IncHIV-1 / HIV-2 Plus O EIA Testing SoftwareAn error was contained on the ETI-LAB Applications disk for programming the BioRad HIV-1/HIV-2 Plus O assay.DiaSorin, Inc
Stillwater, Minnesota
5/13/2004Recall of Ortho Assay Software (OAS) Version 2.0 (For Use with the Ortho Summit Sample Handling System)-Ortho Clinical Diagnostics, IncOrtho Assay Software; Version 2.0Ortho Clinical Diagnostics (OCD) has received reports that sample or reagent could be dispensed twice if an 'Error 137' is generated during the pipetting of a plate.Ortho Clinical Diagnostics, Inc.
Raritan, New Jersey
4/23/2004Recall of MTS Anti-IgG Card and MTS A/B/D Monoclonal and Reverse Grouping Card-Micro Typing Systems, IncPRODUCT / LOT NUMBER / EXPIRATION DATE:

MTS Anti-IgG Card / 082203001-14 / 7/15/2004
(Microtube # 1 from left to right with the barcode facing forward)

MTS A/B/D Monoclonal and Reverse Grouping Card / 111903037-11 / 10/23/2004
(Anti-D Microtube)

Micro Typing Systems, Inc. (MTS) has received reports of gel not present in one microtube of a limited number of cards.Micro Typing Systems, Inc
Pompano Beach, FL
4/2/2004Recall of Rabies Vaccine (Human Diploid Cell), Imovax Rabies-Aventis PasteurLOT NUMBER / EXPIRATION DATE :
X0667-2 6/24/2006

X0667-3 6/24/2006

W1419-2 12/6/2005

W1419-3 12/6/2005

 

Aventis Pasteur is recalling four lots of Imovax Rabies, Rabies Vaccine (Human Diploid Cell) that were distributed in the U.S. This is a precautionary measure stemming from the discovery through routine testing of a non-inactivated production strain of virus in a single product lot, which was not distributed.Aventis Pasteur
Swiftwater, PA
4/2/2004Notice to Readers: Manufacturer's Recall of Human Rabies Vaccine-MMWRLOT NUMBER / EXPIRATION DATE :
X0667-2 6/24/2006

X0667-3 6/24/2006

W1419-2 12/6/2005

W1419-3 12/6/2005
These lots were produced during the same period as the lot that contained noninactivated Pitman-Moore virus.Aventis Pasteur
Swiftwater, PA
4/1/2004Recall of Immune Globulin Intravenous (Human), Gammar-P I.V., 10 gm-Aventis Behring L.L.C.LOT NUMBER / EXPIRATION DATE:
A639110 10/23/2006

A639210 10/23/2006

 

These lots exhibit an increased frequency of non-serious, labeled adverse events associated with allergic reactions.Aventis Behring L.L.C.
Bradley, IL
3/12/2004Recall of Allergenic Extracts - Hollister-Stier Laboratories LLCPRODUCT / LOT NUMBER / EXPIRATION DATE:
Acacia Golden / A43C2180 / 7/1/2005

Bahia Grass / A43G3905 & A43C2299 / 7/1/2005

Cedar, Mountain / A43D2458 / 7/1/2005

Cedar, Red / A43F3492, A4314533, A4314535 / 7/1/2005

Elm, American / A43A1158, A43J5006, A43B1876, A43G3710 / 7/1/2005

Maple, Hard/Sugar / A43C2295, A43J5010 / 7/1/2005

Mulberry Mix RW / A4314819, A43G3719 / 7/1/2005

Pecan Tree / A43C1976, A43F3351, A43B1633 / 7/1/2005

Sagebrush, Mugwort / A43K5605 / 7/1/2005

Sheep Sorrel / A43F3340, A43D2376 / 7/1/2005

Walnut, Black / A4314645, A43F3359, A43E3131 / 7/1/2005

AP Housedust Mix / A43B1925, A43C2128 / 7/1/2005

Alternaria tenuis / A43E3130, A4314725, A43G3906, A43G3810, A43G3812, A43E3133 / 7/1/2005

Candida albicans / A43D2633, A43H4195, A43C2127 / 7/1/2005

Epicoccum nigrum / A43G3707, A43J5339, A43E3203, A43A1469, A4219616 / 7/1/2005

PGM # 4 Grass / G33G3807 7/1/2004

PMG Mite Mix / G33G3805 / 7/1/2004
Hollister-Stier is recalling these lots of allergenic extract because the expiration date printed on the clear overlay label may smear when exposed to moisture.Hollister-Stier Laboratories LLC
Spokane, Washington
1/9/2004Recall of Blood Bank Data Management System Software - Information Data ManagementIDM Surround System, Software versions 3.4, 3.5, and 3.6IDM's Surround System fails to recognize duplicate batches when used in conjunction with the Abbott PPC (Parallel Processing Center) and the TPC (Total Process Control) mode is utilized.Information Data Management
Rosemont, IL

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