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U.S. Department of Health and Human Services

Class 3 Device Recall Monolisa AntiHBs EIA and Monolisa AntiHBs Calibrator Kit

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  Class 3 Device Recall Monolisa AntiHBs EIA and Monolisa AntiHBs Calibrator Kit see related information
Date Initiated by Firm August 11, 2008
Date Posted May 20, 2010
Recall Status1 Terminated 3 on May 20, 2010
Recall Number Z-1620-2010
Recall Event ID 49126
PMA Number P050048 
Product Classification Hepatitis B Test - Product Code LOM
Product Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220;
MONOLISA TM Anti-HBs Calibrator Kit 25219... Bio-Rad Laboratories Redmond, WA 98052"

For the qualitative detection of antibody to Hepatitis B Surface Antigen (anti-HBs) in Human Serum and EDTA or citrated plasma.
Code Information Lot #'s: 288BEE and 056CEE
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories
6565 185th Ave NE
Redmond WA 98052-5039
For Additional Information Contact Christopher Bentsen
425-498-1709
Manufacturer Reason
for Recall		 The package insert provided with this kit contains a typographical error, giving incorrect directions to prepare a Working Conjugate Solution. If these directions are followed, it would result in a 1:6 dilution and invalidate the assay.
FDA Determined
Cause 2		 Packaging process control
Action All domestic customers were notified via an Urgent Product Correction customer letter sent by DHL or FedEx on 8/11/08. Enclosed with the letter was a corrected package insert. The Canadian subsidiary was notified via e-mail on 8/11/08. The letter advised customers of the correct wording, and advised that a new corrected package insert was enclosed and to make note of the correction in the laboratory procedures. Questions should be directed to Bio-Rad Laboratories Technical Support at 1-800-224-6723.
Quantity in Commerce 795 kits
Distribution Worldwide Distribution -- USA and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LOM and Original Applicant = BIO-RAD LABORATORIES
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