BEUDAMED
    FDA Enforcement Class I Terminated

    FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

    Recall: Z-1245-2013 · Reported May 15, 2013

    Enforcement

    Recall Number
    Z-1245-2013
    Event ID
    64876
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    May 15, 2013
    Initiation Date
    April 15, 2013
    Classification Date
    May 9, 2013
    Termination Date
    August 3, 2015
    Address
    1360 S Loop Rd, N/A, Alameda, CA, 94502-7000, United States

    Description

    FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

    Reason

    AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.

    Code Info

    Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.

    Distribution

    Nationwide Distribution

    Quantity

    335,273 meters; 209,336 remain at firm.