BEUDAMED
    FDA Recall Terminated

    cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.

    Recall: Z-1346-2013 · Initiated April 1, 2013

    Recall

    Recall Number
    Z-1346-2013
    Event Number
    64930
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    OOI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 1, 2013
    Posted
    May 21, 2013
    Terminated
    August 7, 2014
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733

    Description

    cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.

    Reason

    In rare instances, channel shifted results have been generated with cobas 4800 assays run on v1.1.1 of the cobas 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported

    Action

    Roche sent an "Urgent Medical Device Correction" (UMDC) notification with response form dated April 1, 2013, to all affected customers via UPS Ground on April 1, 2013. The letter identified the product, the problem, and the action to be taken by the customer. A contact number (Roche Diagnostic Technical Support) is provided for technical support 24 hours a day, seven days a week at phone number: 1-888-912-7090.

    Distribution

    Nationwide Distribution.

    Quantity

    425 instruments