BEUDAMED
    FDA Recall Terminated

    I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.

    Recall: Z-2157-2012 · Initiated March 1, 2012

    Recall

    Recall Number
    Z-2157-2012
    Event Number
    62536
    Firm
    Abbott Point Of Care Inc.
    FEI Number
    2245578
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 1, 2012
    Posted
    August 8, 2012
    Terminated
    February 8, 2013
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.

    Reason

    The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.

    Action

    Abbott Point of Care Inc, sent a URGENT RECALL NOTICE dated March 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were provided in the letter with instructions in the letter on how to handle the affected product. Please complete and return the enclosed Business Reply card to acknowledge receipt of this communication and installation of the interium software CLEW and also 1) Update all handhelds 2) download appropriate assignment sheets. For further questions please call (609) 454-9000.

    Distribution

    Worldwide Distribution -- (USA) nationwide

    Quantity

    2,950,296 cartridges US; 156,408 cartridges OUS