BEUDAMED
    FDA Recall Terminated

    i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.

    Recall: Z-0456-2011 · Initiated March 17, 2010

    Recall

    Recall Number
    Z-0456-2011
    Event Number
    55178
    Firm
    Abbott Point of Care Inc.
    FEI Number
    2245578
    Product Code
    CGL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 17, 2010
    Posted
    November 24, 2010
    Terminated
    September 22, 2011
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.

    Reason

    The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.

    Action

    Abbott Point of Care issued Urgent Product Recall Notification letters dated March 2010 to all direct customers identifying the affected product and the actions to be taken. Customers were instructed to determine if they had cartirdges that had been stored above 25 degrees Celsius, and if so, contact Abbott for replacement or credit. Abbott Technical Support can be contacted at 800-366-8020 option 1 about this recall.

    Distribution

    Worldwide Distribution: Throughout USA and Canada.

    Quantity

    34525 cartridges