BEUDAMED
    FDA Enforcement Class II Ongoing

    Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.

    Recall: Z-1009-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-1009-2023
    Event ID
    91286
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Molecular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2023
    Initiation Date
    December 9, 2022
    Classification Date
    January 20, 2023
    Address
    1300 E Touhy Ave, N/A, Des Plaines, IL, 60018-3315, United States

    Description

    Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.

    Reason

    The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.

    Code Info

    Model Number: 08N53-002

    Distribution

    x

    Quantity

    918 units