BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0944-2022 · Initiated March 4, 2022

    Recall

    Recall Number
    Z-0944-2022
    Event Number
    89975
    Firm
    SML Distribution, LLC
    FEI Number
    3022161362
    Product Code
    QKP
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    March 4, 2022
    Address
    1500-1631 Lincoln Ave., tyrone, PA, 16686

    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.

    Action

    The firm initially contacted affected customers by phone between March 4 and March 12, 2022. On March 21, 2022, the firm followed up with emails to each affected distributor with subject line "IMPORTANT!!! Recall Notice" which included a recall letter attachment. Customers were asked to immediately return all unused product. The firm sent an additional email on March 25, 2022 which instructed customers to not rely on the recalled tests to make medical decisions. As of April 9, 2022, the full recall notice can be found at www.smldistribution.com.

    Distribution

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

    Quantity

    209,450 units