BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0680-2022 · Initiated December 2, 2021

    Recall

    Recall Number
    Z-0680-2022
    Event Number
    89516
    Firm
    CELLTRION USA INC
    FEI Number
    3015423092
    Product Code
    QKP
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 2, 2021
    Posted
    March 2, 2022
    Terminated
    June 10, 2024
    Address
    1 Evertrust Plz, Ste 1207, Jersey City, NJ, 07302-3087

    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.

    Action

    On December 2, 2021, the firm notified the affected distributor that the two lots are Research Use Only and should not be used. The distributor then notified the customer. Customer reported all product had been used.

    Distribution

    Distributed to TX.

    Quantity

    8080 kits originally distributed; 726 kits redistributed