BEUDAMED
    FDA Enforcement Class II Ongoing

    FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test

    Recall: Z-0421-2022 · Reported January 5, 2022

    Enforcement

    Recall Number
    Z-0421-2022
    Event ID
    89028
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Migo Trading LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 5, 2022
    Initiation Date
    November 4, 2021
    Classification Date
    December 27, 2021
    Address
    831 Laca St, Dayton, NV, 89403-6394, United States

    Description

    FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test

    Reason

    Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use.

    Code Info

    UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023

    Distribution

    NY

    Quantity

    200,100 units