BEUDAMED
    FDA Enforcement Class II Terminated

    Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.

    Recall: Z-2403-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2403-2012
    Event ID
    62738
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2012
    Initiation Date
    April 23, 2012
    Classification Date
    September 18, 2012
    Termination Date
    February 12, 2014
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733, United States

    Description

    Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.

    Reason

    When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order.

    Code Info

    05666678001

    Distribution

    Nationwide (USA) Distribution

    Quantity

    1292 instruments