BEUDAMED
    FDA Recall Terminated

    i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540

    Recall: Z-0318-2011 · Initiated January 1, 2008

    Recall

    Recall Number
    Z-0318-2011
    Event Number
    56668
    Firm
    Abbott Point Of Care Inc.
    FEI Number
    2245578
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 1, 2008
    Posted
    November 3, 2010
    Terminated
    September 14, 2011
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540

    Reason

    i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.

    Action

    Abbott Point Of Care Inc.sent notification letters with a customer reply form to all affected customer in January, 2008. All distributors outside the US who were sent shipments from the affected lots were notified of the lot numbers that were affected. Affected product is to be quarantined and returned for replacement. Customers with questions about this recall can contact Abbott Point Of Care at 609 454-9000.

    Distribution

    Worldwide Distribution: USA and Canada.

    Quantity

    482,500 (total)