BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0659-2022 · Initiated December 28, 2021

    Recall

    Recall Number
    Z-0659-2022
    Event Number
    89508
    Firm
    CELLTRION USA INC
    FEI Number
    3015423092
    Product Code
    QKP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 28, 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

    The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.

    Action

    The firm initially placed a hold on product due to complaints of false positive and false negative results in September 2021. After product was erroneously distributed from this lot in December 2021, the firm notified affected customers that the lot should not have been distributed and should not be used. This email went out on or around December 28, 2021. Customers were instructed to NOT use the affected lot.

    Distribution

    US distribution to CA, FL, NJ, NY, PA, SC.

    Quantity

    243 kits (6,075 tests)