BEUDAMED
    FDA Recall 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 · Initiated October 11, 2012

    Recall

    Recall Number
    Z-0614-2013
    Event Number
    63814
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    JJH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 11, 2012
    Posted
    December 23, 2012
    Terminated
    September 11, 2013
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733

    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.

    Action

    Roche sent an Urgent Medical Device Correction notification/Fax Back forms dated 10/11/12 to potentially affected customers. The letter identified the affected product, the issue, clinical significance, workaround, and required actions, along with contact information. Customers are to use the workaround until their Roche FSE has performed a Master Initialization on their affected instruments. Also, the letter should be filed for future reference. Questions should be directed to Roche Molecular Diagnostics Technical Support at 1-800-526-1247.

    Distribution

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

    Quantity

    7 units