BEUDAMED
    FDA Recall Terminated

    The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.

    Recall: Z-0490-2013 · Initiated July 16, 2012

    Recall

    Recall Number
    Z-0490-2013
    Event Number
    63312
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    NSX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 16, 2012
    Posted
    December 7, 2012
    Terminated
    July 22, 2015
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733

    Description

    The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.

    Reason

    Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

    Action

    Roche sent an "Urgent Medical Device Correction" (UMDC) notification letter dated July 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Molecular Systems, Inc. has disabled this software on affected Roche platforms and discontinued the distribution of the affected software. Contact Roche Diagnostic Technical Support, 24 hours a day, seven days a week at phone number : 1-800-428-2336 if you have questions regarding this notification. For questions regarding this recall call 908-253-7569.

    Distribution

    Nationwide Distribution

    Quantity

    855 units.