BEUDAMED
    FDA Enforcement Class III Ongoing

    Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

    Recall: Z-0958-2023 · Reported January 25, 2023

    Enforcement

    Recall Number
    Z-0958-2023
    Event ID
    91303
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2023
    Initiation Date
    November 24, 2022
    Classification Date
    January 17, 2023
    Address
    1915 Hurd Dr, N/A, Irving, TX, 75038, United States

    Description

    Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

    Reason

    Reaction vessels may contain a potential contaminant that could affect their optical performance.

    Code Info

    UDI-DI/Lots: 00380740129026/000586790 and 000586879

    Distribution

    US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV

    Quantity

    70 cases