BEUDAMED
    FDA Enforcement Class II Ongoing

    DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

    Recall: Z-2267-2025 · Reported August 13, 2025

    Enforcement

    Recall Number
    Z-2267-2025
    Event ID
    97162
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 13, 2025
    Initiation Date
    June 25, 2025
    Classification Date
    August 5, 2025
    Address
    1000 Lake Hazeltine Dr, N/A, Chaska, MN, 55318-1037, United States

    Description

    DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

    Reason

    Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.

    Code Info

    UDI-DI: 15099590369231; Serial Numbers: 608109

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    1 system