BEUDAMED
    FDA Enforcement Class II Terminated

    COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland

    Recall: Z-0614-2013 · Reported January 2, 2013

    Enforcement

    Recall Number
    Z-0614-2013
    Event ID
    63814
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2013
    Initiation Date
    October 11, 2012
    Classification Date
    December 22, 2012
    Termination Date
    September 11, 2013
    Address
    1080 Us Highway 202 S, N/A, Branchburg, NJ, 08876-3733, United States

    Description

    COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland

    Reason

    Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.

    Code Info

    CAP 394436 to 394663

    Distribution

    Distributed in the states of GA, CA, NC, and MN.

    Quantity

    7 units