BEUDAMED
    FDA Recall Terminated

    AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.

    Recall: Z-1127-2021 · Initiated January 19, 2021

    Recall

    Recall Number
    Z-1127-2021
    Event Number
    87300
    Firm
    Sky Medical Supplies and Equipments LLC
    FEI Number
    3011895419
    Product Code
    QKO
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    January 19, 2021
    Terminated
    March 10, 2026
    Address
    5987 Nw 102nd Ave, Doral, FL, 33178-2820

    Description

    AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.

    Reason

    Distributed COVID test kits without emergency use authorization.

    Action

    Sky Medical initiated the recall on 01/19/2021 by telephone. The firm sent a follow-up letter disseminated by email on 02/03/2021. The firm is requesting the return of the product.

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.

    Quantity

    10,000 kits