BEUDAMED
    FDA Enforcement Class I Ongoing

    STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.

    Recall: Z-0719-2022 · Reported March 23, 2022

    Enforcement

    Recall Number
    Z-0719-2022
    Event ID
    89527
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SD Biosensor, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2022
    Initiation Date
    January 31, 2022
    Classification Date
    March 15, 2022
    Address
    1556 Beon-Gil, Yeongtong, C4th & 5th Floor Digital Empire Bldg, 16, Deogyeong-Daero, Suwon, N/A, N/A, Korea (the Republic of)

    Description

    STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.

    Reason

    Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

    Code Info

    REF No. Q-NCOV-03G Catalog No.: 09COV130 Lot Number: 59628J1T1 (Potentially 59628J1T1/2)

    Distribution

    U.S. Nationwide Distribution

    Quantity

    ~400,000 kits