BEUDAMED
    FDA Enforcement Class II Completed

    The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.

    Recall: Z-1518-2022 · Reported August 24, 2022

    Enforcement

    Recall Number
    Z-1518-2022
    Event ID
    90651
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Abbott Molecular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2022
    Initiation Date
    July 19, 2022
    Classification Date
    August 12, 2022
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315, United States

    Description

    The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.

    Reason

    Incorrect optical calibration

    Code Info

    Serial Number 00654

    Distribution

    There was only foreign distribution to Italy.

    Quantity

    1