BEUDAMED
    FDA Recall Terminated

    Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190

    Recall: Z-2361-2019 · Initiated July 16, 2019

    Recall

    Recall Number
    Z-2361-2019
    Event Number
    83416
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    NHX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 16, 2019
    Posted
    August 23, 2019
    Terminated
    April 30, 2021
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190

    Reason

    Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.

    Action

    Customers will be instructed to only use serum samples when testing with one of the affected lots numbers. Re-measure the sample if an implausible result occurs while using plasma samples, and a high Anti-CCP result does not match the patients clinical picture. To follow the work-around provided in the UMDC concerning pre-analytical sample handling for plasma samples. Perform maintenance according to the operator manual (e.g., Liquid Flow Cleaning [LFC]) to ensure proper functioning of the analyzer or module. Customers will be reminded that sample quality can be affected by fibrin clots and how this significantly impacts the Anti-CCP results. 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. ***Updated 7/17/20*** An updated letter was sent out to customers on July 13, 2020. After further investigation, Roche has decided to remove human plasma as a sample type from the intended use and remove all claims associated with the plasma sample type. The change is applicable for all current and upcoming lots. Customer actions required: " Use the Elecsys Anti-CCP assay with serum samples only for all current and future Elecsys Anti-CCP lot numbers. " ALL customers, complete the response form included with the letter and return to the firm " If you cannot run serum samples in your laboratory, complete the Product Information section of the response form to obtain reagent credit or contact your Roche sales representative for further options. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference. " Discard Urgent Medical Device Correction TP-00714 if you previously received it.

    Distribution

    AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA

    Quantity

    135 units