BEUDAMED
    FDA Recall Terminated

    cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122

    Recall: Z-0108-2020 · Initiated August 28, 2019

    Recall

    Recall Number
    Z-0108-2020
    Event Number
    83758
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    DDG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 28, 2019
    Terminated
    October 2, 2020
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122

    Reason

    Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference

    Action

    Roche issued notification to consignees by Urgent Medical Device Correction (TP-00754) sent via UPS (signature required) on 8/28/19. The UMDC will also be available on diagnostics.roche.com. The letter identifies the problem, risk to health and action to take: Be aware of new interference claims that are listed in this UMDC and that the rhEPO Therapy Monitoring Statement will be removed from the Method Sheets. The UMDC will serve as intermediate labeling until the updated method sheets are available. Complete all sections of the enclosed fax form. 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 if you have questions

    Distribution

    Nationwide

    Quantity

    6,494 units