BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0953-2022 · Initiated April 1, 2022

    Recall

    Recall Number
    Z-0953-2022
    Event Number
    89965
    Firm
    CELLTRION USA INC
    FEI Number
    3015423092
    Product Code
    QKP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 1, 2022
    Posted
    April 27, 2022
    Terminated
    June 11, 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

    Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.

    Action

    On April 1, 2022, the firm notified distributors of the issue via letter, following up with meetings with each distributor on April 5, 2022 and emails on April 6, 2022. The firm instructed distributors to communicate the recall to their affected customers, down to the user level. Customers who do not have CLIA IDs must return the product to their distributors.

    Distribution

    US Nationwide distribution.

    Quantity

    12,632 kits