BEUDAMED
    FDA Enforcement Class II Terminated

    i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.

    Recall: Z-1306-2014 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1306-2014
    Event ID
    67513
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Point Of Care Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 2, 2014
    Initiation Date
    January 1, 2014
    Classification Date
    March 27, 2014
    Termination Date
    October 20, 2014
    Address
    400 College Rd E, N/A, Princeton, NJ, 08540-6607, United States

    Description

    i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.

    Reason

    Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.

    Code Info

    List number 03P78-25 :Lot number N13183

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada.

    Quantity

    48, 450 US, 1400 OUS (49,850 catridges)