BEUDAMED
    FDA Enforcement Class II Ongoing

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.

    Recall: Z-0738-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0738-2022
    Event ID
    89675
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NeuMoDx Molecular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    March 16, 2022
    Initiation Date
    January 21, 2022
    Classification Date
    March 8, 2022
    Address
    1250 Eisenhower Pl, N/A, Ann Arbor, MI, 48108-3281, United States

    Description

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.

    Reason

    A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.

    Code Info

    Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830

    Distribution

    US Nationwide distribution in the states of FL, MD, MI, NY.

    Quantity

    102 boxes