BEUDAMED
    FDA Recall Terminated

    "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" The test kit contains slides and substrate. For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies.

    Recall: Z-3051-2011 · Initiated June 30, 2010

    Recall

    Recall Number
    Z-3051-2011
    Event Number
    56251
    Firm
    Bio-Rad Laboratories
    FEI Number
    3008272466
    Product Code
    DHN
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 30, 2010
    Posted
    August 22, 2011
    Terminated
    August 22, 2011
    Address
    6565 185th Ave NE, Redmond, WA, 98052-5039

    Description

    "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" The test kit contains slides and substrate. For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies.

    Reason

    KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.

    Action

    Bio-Rad Laboratories notified affected customers by phone on 6/30/2010 and followed up with a 2nd call on 7/13/2010. The call informed customers of the problem with the kit and requested they destroy the Crithidia slide packs. Bio-Rad send out replacement slide packs. For information or questions on this recall call Bio-Rad at (425) 498-1709.

    Distribution

    Worldwide Distribution: (USA) Nationwide distribution including the states of CT, OK; and the country of Puerto Rico.

    Quantity

    224 kits were distributed; 35 of those kits were determined to contain the wrong slides.