BEUDAMED
    FDA Recall Open, Classified

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer

    Recall: Z-1664-2025 · Initiated March 27, 2025

    Recall

    Recall Number
    Z-1664-2025
    Event Number
    96554
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    March 27, 2025
    Posted
    April 24, 2025
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    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.

    Action

    Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/27/2025 via USPS first class mail. The notice explained the issue with the device, impact to the patient, and provided a workaround until a software upgrade is available. If the consignee further distributed the affected device, they were directed to provide a copy of the notice to the recipient. For questions, contact Customer Support Center, from the website: http://www.beckmancoulter.com

    Distribution

    Worldwide distribution.

    Quantity

    370 units