BEUDAMED
    FDA Recall Completed

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

    Recall: Z-1115-2025 · Initiated January 3, 2024

    Recall

    Recall Number
    Z-1115-2025
    Event Number
    96103
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    JJE
    Status
    Completed
    Root Cause
    Software design
    Initiated
    January 3, 2024
    Posted
    February 6, 2025
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    Description

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

    Reason

    A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.

    Action

    A field service engineer was dispatched to the customer site to perform the software update and to replace the PCB TSI-RSI board from 01/03/2024 through 12/26/2024.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brazil, Croatia, France, Germany, Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland.

    Quantity

    61 units