BEUDAMED
    FDA Enforcement Class II Ongoing

    Diagnostic Kit SARS-cCo V Antigen Rapid Test

    Recall: Z-1050-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1050-2022
    Event ID
    90098
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    USA Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2022
    Initiation Date
    April 4, 2022
    Classification Date
    May 6, 2022
    Address
    1220 Texan Trl Ste 205, N/A, Grapevine, TX, 76051-4164, United States

    Description

    Diagnostic Kit SARS-cCo V Antigen Rapid Test

    Reason

    COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.

    Code Info

    Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None

    Distribution

    U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.

    Quantity

    2055 kits