BEUDAMED
    FDA Enforcement Class II 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 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2157-2012
    Event ID
    62536
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Point Of Care Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    March 1, 2012
    Classification Date
    August 8, 2012
    Termination Date
    February 8, 2013
    Address
    400 College Rd E, Princeton, NJ, 08540-6607, United States

    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.

    Code Info

    List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12

    Distribution

    Worldwide Distribution -- (USA) nationwide

    Quantity

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