BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0421-2022 · Initiated November 4, 2021

    Recall

    Recall Number
    Z-0421-2022
    Event Number
    89028
    Firm
    Migo Trading LLC
    FEI Number
    3018125969
    Product Code
    QKP
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    November 4, 2021
    Address
    831 Laca St, Dayton, NV, 89403-6394

    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.

    Action

    On November 4, 2021, Migo Trading issued URGENT MEDICAL DEVICE RECALL notices and response forms dated November 1, 2021 to customers via email. Actions to be taken by the Customer/User: - Please inspect stock and quarantine impacted product. - Please discard any available inventory in your possession or by your customer s possession. - If you have used these devices to determine your SARS-CoV-2 infection status, it is possible that your test result is incorrect. It is recommended that you obtain a confirmatory test to determine your SARS-CoV-2 infection status. - Complete and return the attached response form via email at [email protected]

    Distribution

    NY

    Quantity

    200,100 units