BEUDAMED
    FDA Enforcement Class II Terminated

    ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

    Recall: Z-0645-2013 · Reported January 16, 2013

    Enforcement

    Recall Number
    Z-0645-2013
    Event ID
    63829
    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
    January 16, 2013
    Initiation Date
    September 20, 2012
    Classification Date
    January 7, 2013
    Termination Date
    March 12, 2013
    Address
    34 Bunsen, Irvine, CA, 92618-4210, United States

    Description

    ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

    Reason

    Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software

    Code Info

    Lot/Serial# PML0937

    Distribution

    Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.

    Quantity

    10 units