BEUDAMED
    FDA Enforcement Class II Terminated

    Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.

    Recall: Z-1173-2014 · Reported March 19, 2014

    Enforcement

    Recall Number
    Z-1173-2014
    Event ID
    67528
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Horiba Instruments, Inc dba Horiba Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 19, 2014
    Initiation Date
    February 14, 2014
    Classification Date
    March 10, 2014
    Termination Date
    August 22, 2014
    Address
    34 Bunsen, N/A, Irvine, CA, 92618-4210, United States

    Description

    Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.

    Reason

    HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.

    Code Info

    Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A

    Distribution

    USA Nationwide Distribution

    Quantity

    15