BEUDAMED
    FDA Enforcement Class II Ongoing

    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

    Recall: Z-0943-2026 · Reported December 24, 2025

    Enforcement

    Recall Number
    Z-0943-2026
    Event ID
    97961
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Copan Italia
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 24, 2025
    Initiation Date
    October 29, 2025
    Classification Date
    December 18, 2025
    Address
    Via Francesco Perotti 10, 18, Brescia, N/A, Italy

    Description

    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

    Reason

    Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

    Code Info

    UDI:0U020N.A - (01)18053326005043

    Distribution

    US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT

    Quantity

    122,850 units US