BEUDAMED
    FDA Enforcement Class II Ongoing

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

    Recall: Z-1251-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1251-2022
    Event ID
    90275
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NeuMoDx Molecular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2022
    Initiation Date
    May 13, 2022
    Classification Date
    June 8, 2022
    Address
    1250 Eisenhower Pl, Ann Arbor, MI, 48108-3281, United States

    Description

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

    Reason

    There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.

    Code Info

    UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508

    Distribution

    Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.

    Quantity

    459 kits US; 1626 kits OUS