BEUDAMED
    FDA Enforcement Class II Ongoing

    DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01

    Recall: Z-3306-2024 · Reported October 9, 2024

    Enforcement

    Recall Number
    Z-3306-2024
    Event ID
    95288
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 9, 2024
    Initiation Date
    June 26, 2024
    Classification Date
    September 27, 2024
    Address
    No. 1304 Science And Technology Innovation Park, Shajing Dahong, N/A, Shenzhen, N/A, N/A, China

    Description

    DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01

    Reason

    The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

    Code Info

    All lots in the United States

    Distribution

    International distribution to the countries of China and Hong Kong.

    Quantity

    150,000 kits