BEUDAMED
    FDA Enforcement Class II 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 · Reported February 24, 2021

    Enforcement

    Recall Number
    Z-1127-2021
    Event ID
    87300
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sky Medical Supplies and Equipments LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 24, 2021
    Initiation Date
    January 19, 2021
    Classification Date
    February 16, 2021
    Termination Date
    March 10, 2026
    Address
    5987 Nw 102nd Ave, N/A, Doral, FL, 33178-2820, United States

    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.

    Code Info

    2020042901

    Distribution

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

    Quantity

    10,000 kits