BEUDAMED
    FDA Enforcement Class I Ongoing

    Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

    Recall: Z-0944-2022 · Reported May 11, 2022

    Enforcement

    Recall Number
    Z-0944-2022
    Event ID
    89975
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SML Distribution, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 11, 2022
    Initiation Date
    March 4, 2022
    Classification Date
    May 3, 2022
    Address
    1500-1631 Lincoln Ave., N/A, tyrone, PA, 16686, United States

    Description

    Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

    Reason

    The product was distributed without FDA authorization or clearance for marketing and distribution in the US.

    Code Info

    All lots: UL-AG-2110-05-Q UL-AG-2111-02-Q UL-AG-2112-01-Q UL-AG-2112-02-Q UL-AG-2201-03-Q

    Distribution

    US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.

    Quantity

    209,450 units