BEUDAMED
    FDA Enforcement Class I Terminated

    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

    Recall: Z-0680-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0680-2022
    Event ID
    89516
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    CELLTRION USA INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 9, 2022
    Initiation Date
    December 2, 2021
    Classification Date
    March 2, 2022
    Termination Date
    June 10, 2024
    Address
    1 Evertrust Plz Ste 1207, Jersey City, NJ, 07302-3087, United States

    Description

    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

    Reason

    Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.

    Code Info

    Lots COVGCCF0001, COVGCCF0002

    Distribution

    Distributed to TX.

    Quantity

    8080 kits originally distributed; 726 kits redistributed