BEUDAMED
    FDA Recall 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 · Initiated December 1, 2021

    Recall

    Recall Number
    Z-0558-2022
    Event Number
    89455
    Firm
    CELLTRION USA INC
    FEI Number
    3015423092
    Product Code
    QKP
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    December 1, 2021
    Terminated
    June 17, 2024
    Address
    1 Evertrust Plz, Ste 1207, Jersey City, NJ, 07302-3087

    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.

    Action

    Celltrion Healthcare informs Celltrion USA on 2021-11-11 that it had sent cease and desist letter to distributors who were illegally distributing non-EUA product in the U.S. Celltrion demanded return of all EU product from distributors' inventory and demanded removal of all EU DiaTrustTests from the U.S. In addition, the firm sent letters to all EU distributors warning against diversion and obtaining confirmation that distributors understand limitations on distribution only within the EU.

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    162,000 ea