BEUDAMED
    FDA Recall Completed

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

    Recall: Z-1518-2022 · Initiated July 19, 2022

    Recall

    Recall Number
    Z-1518-2022
    Event Number
    90651
    Firm
    Abbott Molecular, Inc.
    FEI Number
    3005248192
    Product Code
    MZP
    Status
    Completed
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 19, 2022
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    Description

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

    Reason

    Incorrect optical calibration

    Action

    The recalling firm issued a letter dated 7/19/2022 via Abbott representative delivery on 7/19/2022 confirming the issue the customer had with their instrument. The letter also said the impacted ADU4 module was taken out of service on 1/25/2022 and was then replaced with a new module on 3/22/2022. The letter discussed the potential impact and the necessary actions to take which included completing and returning the Customer Reply Form and reviewing this information with laboratory personnel and retain the communication for future reference.

    Distribution

    There was only foreign distribution to Italy.

    Quantity

    1