BEUDAMED
    FDA Recall Terminated

    BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control included in lot is identified as "REF 425-2025" and "LOT CPM-591". in vitro diagnostic.

    Recall: Z-1145-2010 · Initiated July 14, 2009

    Recall

    Recall Number
    Z-1145-2010
    Event Number
    52889
    Firm
    Bio-Rad Laboratories Inc
    FEI Number
    2915274
    Product Code
    DHC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 14, 2009
    Posted
    March 16, 2010
    Terminated
    March 18, 2011
    Address
    4000 Alfred Nobel Dr, Hercules, CA, 94547-1803

    Description

    BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control included in lot is identified as "REF 425-2025" and "LOT CPM-591". in vitro diagnostic.

    Reason

    The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.

    Action

    Bio-Rad initiated its field correction on July 14, 2009. The firm notified domestic consignees by phone followed by fax, and each subsidiary will be given an urgent notice, subsidiary response form, customer medical device correction notification, acknowledgement form and a listing of consignees. The subsidiaries must contact customers as instructed.

    Distribution

    Worldwide distribution: USA, Australia, Canada, France, Italy, Korea, Mexico, Panama, Singapore, and Trinidad.

    Quantity

    213 kits