BEUDAMED
    FDA Enforcement Class II Ongoing

    cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190

    Recall: Z-1105-2023 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1105-2023
    Event ID
    91482
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2023
    Initiation Date
    December 21, 2022
    Classification Date
    February 7, 2023
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733, United States

    Description

    cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190

    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.

    Code Info

    UDI-DI 00875197006827 All in-date lots

    Distribution

    Domestic distribution nationwide. Foreign distribution worldwide.

    Quantity

    9,948 OUS only