BEUDAMED
    FDA Enforcement Class II Terminated

    Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.

    Recall: Z-0558-2022 · Reported February 9, 2022

    Enforcement

    Recall Number
    Z-0558-2022
    Event ID
    89455
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CELLTRION USA INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 9, 2022
    Initiation Date
    December 1, 2021
    Classification Date
    February 3, 2022
    Termination Date
    June 17, 2024
    Address
    1 Evertrust Plz Ste 1207, N/A, Jersey City, NJ, 07302-3087, United States

    Description

    Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.

    Reason

    The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.

    Code Info

    All lots

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    162,000 ea