BEUDAMED
    FDA Enforcement Class II Ongoing

    ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.

    Recall: Z-1248-2025 · Reported March 5, 2025

    Enforcement

    Recall Number
    Z-1248-2025
    Event ID
    96176
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TERRAGENE S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2025
    Initiation Date
    January 15, 2025
    Classification Date
    February 27, 2025
    Address
    Ruta Nacional N 9, Km 280, Cp 2130, Parque Industrial Micropi, Alvear, N/A, N/A, Argentina

    Description

    ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.

    Reason

    Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.

    Code Info

    Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.

    Distribution

    US Nationwide distribution in the states of CA and KY.

    Quantity

    914 devices in the U.S.