BEUDAMED
    FDA Recall Terminated

    i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01 24 IVD Abbott Point of Care Inc. 104 Windsor Center Drive East Windsor, NJ 08520 Product of Canada

    Recall: Z-0364-2007 · Initiated December 12, 2006

    Recall

    Recall Number
    Z-0364-2007
    Event Number
    36991
    Firm
    Abbott Point of Care Inc.
    FEI Number
    2245578
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 12, 2006
    Posted
    January 23, 2007
    Terminated
    August 15, 2007
    Address
    104 Windsor Center Dr, East Windsor, NJ, 08520-1407

    Description

    i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01 24 IVD Abbott Point of Care Inc. 104 Windsor Center Drive East Windsor, NJ 08520 Product of Canada

    Reason

    Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges.

    Action

    Customers were notified by letter sent by regular mail on 12/13/2006.

    Distribution

    Nationwide to hospitals and health care facilities

    Quantity

    14,045 boxes of 24