BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0731-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0731-2022
    Event ID
    89640
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CELLTRION USA INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    March 16, 2022
    Initiation Date
    February 25, 2022
    Classification Date
    March 8, 2022
    Address
    1 Evertrust Plz Ste 1207, N/A, Jersey City, NJ, 07302-3087, United States

    Description

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

    Reason

    Kits were labeled with incorrect expiration dates.

    Code Info

    Lot Numbers: COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007

    Distribution

    The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.

    Quantity

    1,228,200 tests