BEUDAMED
    FDA Recall Terminated

    Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190

    Recall: Z-2981-2020 · Initiated August 20, 2020

    Recall

    Recall Number
    Z-2981-2020
    Event Number
    86319
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    JZO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 20, 2020
    Terminated
    October 22, 2021
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190

    Reason

    Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.

    Action

    Urgent Medical Device Correction notification letters dated 8/20/20 were distributed to customers. Actions Required " Be aware of the new RF interference claims listed in this Urgent Medical Device Correction (UMDC). This UMDC serves as labeling until the updated method sheet (V3), anticipated in September 2020, is available. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. Customers do not need to perform an additional RF test unless otherwise determined in consultation with the physician or pathologist at your facility. " Complete the attached fax back form (TP-01048) and fax or email it according to the instructions on the form. " File this UMDC for future reference. Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. The Elecsys Anti-TPO method sheet is being updated with the new claim for Rheumatoid Factor (RF) interference. Until the updated method sheet (V3) is available, this Urgent Medical Device Correction serves as your labeling. When these method sheets are updated, they will be available on the diagnostics.roche.com website and on the cobas e-library. 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

    US Nationwide

    Quantity

    11,870 reagent kits