BEUDAMED
    FDA Enforcement Class II Terminated

    i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

    Recall: Z-1976-2012 · Reported July 18, 2012

    Enforcement

    Recall Number
    Z-1976-2012
    Event ID
    62319
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Point Of Care Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2012
    Initiation Date
    September 8, 2011
    Classification Date
    July 9, 2012
    Termination Date
    January 28, 2013
    Address
    400 College Rd E, Princeton, NJ, 08540-6607, United States

    Description

    i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

    Reason

    Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.

    Code Info

    i-Stat1 Abaxis Analyzer 6000-0000 All lots

    Distribution

    Worldwide Distribution - USA (nationwide)

    Quantity

    6000-0000-650 units