BEUDAMED
    FDA Recall Open, Classified

    Detect Covid-19 Test Product/Model Number: 21205

    Recall: Z-0879-2023 · Initiated December 8, 2022

    Recall

    Recall Number
    Z-0879-2023
    Event Number
    91300
    Firm
    Detect Headquarters
    FEI Number
    3018103650
    Product Code
    QKP
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    December 8, 2022
    Posted
    January 4, 2023
    Address
    351 New Whitfield St, Guilford, CT, 06437-3400

    Description

    Detect Covid-19 Test Product/Model Number: 21205

    Reason

    There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.

    Action

    On December 8, 2022, the firm notified affected enterprise/wholesale customers through email with subject line "URGENT: Voluntary Recall of Three Lots of Detect Covid-19 Tests". Direct customers were notified on December 12, 2022. Customers were instructed to locate unused tests from the affected lots and dispose of them. Customers may receive a refund for the recalled tests once they complete an acknowledgement form and return it to Detect.

    Distribution

    Domestic distribution nationwide. Foreign distribution to Hong Kong.

    Quantity

    10142 (US); 960 OUS