BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1251-2022 · Initiated May 13, 2022

    Recall

    Recall Number
    Z-1251-2022
    Event Number
    90275
    Firm
    NeuMoDx Molecular Inc
    FEI Number
    3010729479
    Product Code
    QLT
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 13, 2022
    Address
    1250 Eisenhower Pl, Ann Arbor, MI, 48108-3281

    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.

    Action

    On May 13, 2022, the firm distributed Urgent Medical Device Correction letters to impacted customers. The letter informed customers of the reduced analytical sensitivity for Flu A, SARS-CoV-2, and RSV. The firm also specified that only the RSV target showed a similar reduction in clinical sensitivity; Influenza A and SARS-CoV-2 did not show a reduction in clinical sensitivity. Influenza B is not affected by this issue. The letter reminded users that negative results do not preclude infection with Influenza virus, RSV, and/or SARS-CoV-2, and the device should not be used as the sole basis for patient management and treatment decisions. Customers should share the notice with all affected users. If you have any questions regarding this recall, please contact QIAGEN Technical Services at 1-800-362-7737 or [email protected].

    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