BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1620-2010 · Initiated August 11, 2008

    Recall

    Recall Number
    Z-1620-2010
    Event Number
    49126
    Firm
    Bio-Rad Laboratories
    FEI Number
    3008272466
    Product Code
    LOM
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 11, 2008
    Posted
    May 20, 2010
    Terminated
    May 20, 2010
    Address
    6565 185th Ave NE, Redmond, WA, 98052-5039

    Description

    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.

    Reason

    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.

    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.

    Distribution

    Worldwide Distribution -- USA and Canada.

    Quantity

    795 kits