BEUDAMED
    FDA Enforcement Class I Terminated

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

    Recall: Z-0953-2022 · Reported May 4, 2022

    Enforcement

    Recall Number
    Z-0953-2022
    Event ID
    89965
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    CELLTRION USA INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2022
    Initiation Date
    April 1, 2022
    Classification Date
    April 27, 2022
    Termination Date
    June 11, 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

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

    Code Info

    All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022.

    Distribution

    US Nationwide distribution.

    Quantity

    12,632 kits