BEUDAMED
    FDA Recall Open, Classified

    Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

    Recall: Z-1045-2022 · Initiated April 9, 2022

    Recall

    Recall Number
    Z-1045-2022
    Event Number
    89995
    Firm
    Woodside Acquisitions Inc.
    FEI Number
    3022253625
    Product Code
    QKP
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    April 9, 2022
    Address
    1625 Lincoln Ave., tyrone, PA, 16686

    Description

    Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

    Reason

    Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

    Action

    On April 9, 2022, the firm notified affected distributors via email with subject line "IMPORTANT!!! Recall Notice". The attached recall letter instructed distributors to immediately return all unused product to the recalling firm for a refund. If distributors have further distributed the product, they should forward the recall information to all affected customer accounts. The firm may be reached Monday through Friday, 9:00 AM to 4:30 PM, Eastern Time at 814-218-2804.

    Distribution

    US distributions to states of: AL and GA.

    Quantity

    17,000 units