BEUDAMED
    FDA Recall Open, Classified

    cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190

    Recall: Z-1106-2023 · Initiated December 21, 2022

    Recall

    Recall Number
    Z-1106-2023
    Event Number
    91482
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    QLT
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    December 21, 2022
    Posted
    February 7, 2023
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733

    Description

    cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190

    Reason

    The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.

    Action

    On December 22, 2022, Roche posted the Urgent Medical Device Correction (UMDC) to its website (dialog.roche.com). On December 27, 2022, the firm also sent UMDC letters to affected customers. Consignees were instructed to monitor for negative influenza A results that are inconsistent with clinical presentation and/or other clinical and epidemiological information. Authorized or licensed Influenza NAATs are available for confirmation if clinically indicated for at-risk patients. Additionally, consignees are reminded to review the tests Instructions for Use, specifically the Intended Use Statements and Procedural Limitations sections, which provide guidance on how negative results should be utilized and mutations within the target regions of the tests can impact detection, respectively. 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 this recall

    Distribution

    Domestic distribution nationwide. Foreign distribution worldwide.

    Quantity

    727 kits OUS only