BEUDAMED
    FDA Enforcement Class II Ongoing

    ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

    Recall: Z-1660-2022 · Reported September 7, 2022

    Enforcement

    Recall Number
    Z-1660-2022
    Event ID
    90692
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2022
    Initiation Date
    July 26, 2022
    Classification Date
    August 30, 2022
    Address
    100 Abbott Park Rd Bldg Ap8b, Abbott Park, IL, 60064-3502, United States

    Description

    ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

    Reason

    One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.

    Code Info

    UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22

    Distribution

    Nationwide

    Quantity

    2451 kits of 100 tests