BEUDAMED
    FDA Enforcement Class II Ongoing

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer

    Recall: Z-1664-2025 · Reported April 30, 2025

    Enforcement

    Recall Number
    Z-1664-2025
    Event ID
    96554
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2025
    Initiation Date
    March 27, 2025
    Classification Date
    April 24, 2025
    Address
    1000 Lake Hazeltine Dr, N/A, Chaska, MN, 55318-1037, United States

    Description

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer

    Reason

    When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

    Code Info

    UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below

    Distribution

    Worldwide distribution.

    Quantity

    370 units