BEUDAMED
    FDA Enforcement Class II Terminated

    Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.

    Recall: Z-1554-2016 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1554-2016
    Event ID
    73349
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Horiba Instruments Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2016
    Initiation Date
    February 19, 2016
    Classification Date
    April 22, 2016
    Termination Date
    August 17, 2016
    Address
    9755 Research Dr, N/A, Irvine, CA, 92618-4626, United States

    Description

    Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.

    Reason

    Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.

    Code Info

    All lot/serial #s

    Distribution

    USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.

    Quantity

    201