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.
FDA Recall Z-1620-2010 · Posted 2010-05-20
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Recalling FirmBio-Rad Laboratories
Recall StatusTerminated
Product CodeLOM
Date Initiated2008-08-11
Date Terminated2010-05-20
Product Quantity795 kits
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.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution -- USA and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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