BEUDAMED
    FDA Recall Terminated

    IMMULITE 2000 Intact PTH kit

    Recall: Z-0724-04 · Initiated February 23, 2004

    Recall

    Recall Number
    Z-0724-04
    Event Number
    28501
    Firm
    Diagnostic Products Corp
    FEI Number
    3005250747
    Product Code
    CEW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 23, 2004
    Posted
    July 20, 2004
    Terminated
    December 2, 2004
    Address
    5700 W 96th St, Los Angeles, CA, 90045-5544

    Description

    IMMULITE 2000 Intact PTH kit

    Reason

    High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.

    Action

    Recall was by letter mailed / faxed on February 23, 2004. Users are instructed to remove EDTA plasma samples for consideration for testing and correct instructions in the package insert.

    Distribution

    North America, Central America, South America, Europe, Asia, South Africa, Middle East. Domestic includes: VA Hospital, St. Louis MO VA Medical Center, Denver, CO VA Medical Center, Richmond, VA VA Medical Center, West Haven, CT Walter Reed Army Medical Center, Washington DC

    Quantity

    2416 kits