BEUDAMED
    FDA Enforcement Class II Terminated

    I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.

    Recall: Z-2133-2012 · Reported August 8, 2012

    Enforcement

    Recall Number
    Z-2133-2012
    Event ID
    62371
    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 8, 2012
    Initiation Date
    January 1, 2011
    Classification Date
    August 2, 2012
    Termination Date
    May 22, 2013
    Address
    400 College Rd E, N/A, Princeton, NJ, 08540-6607, United States

    Description

    I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.

    Reason

    i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.

    Code Info

    List number 03P76-25 Lot number S10246A

    Distribution

    USA ( nationwide )

    Quantity

    52,750 cartridges