BEUDAMED
    FDA Recall Terminated

    Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test

    Recall: Z-1519-2018 · Initiated January 2, 2018

    Recall

    Recall Number
    Z-1519-2018
    Event Number
    79526
    Firm
    Roche Diagnostics Corporation
    FEI Number
    1823260
    Product Code
    LDP
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    January 2, 2018
    Terminated
    April 25, 2019
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test

    Reason

    The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interference section: "In very rare cases, gammopathy, in particular type IgM (Waldenstrm s macroglobulinemia), may cause unreliable results."

    Action

    On January 2, 2018 an URGENT MEDICAL DEVICE CORRECTION letter was issued to customers with notification to the issue and information regarding the updated method sheets and that they were available for use. The COBAS INTEGRA 400 plus/800/800 CTS was updated from affected method sheet version 3.0 to 4.0. The MODULAR ANALYTICS P was updated from affected method sheet version 4.0 to 5.0 No product return is required. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

    Distribution

    Nationwide Distribution

    Quantity

    35,111