BEUDAMED
    FDA Enforcement Class I Terminated

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

    Recall: Z-0659-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0659-2022
    Event ID
    89508
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    CELLTRION USA INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    March 9, 2022
    Initiation Date
    December 28, 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

    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.

    Code Info

    Lot COVGCCM0008

    Distribution

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

    Quantity

    243 kits (6,075 tests)