BEUDAMED
    FDA Recall Open, Classified

    DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461

    Recall: Z-2270-2025 · Initiated June 25, 2025

    Recall

    Recall Number
    Z-2270-2025
    Event Number
    97162
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 25, 2025
    Posted
    August 5, 2025
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    Description

    DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461

    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.

    Action

    An URGENT MEDICAL DEVICE RECALL notification dated 6/25/25 was sent to customers. ACTION: If your laboratory encounters any of the events described in this letter: " Perform a system initialization to resume normal operation. o If repeated initialization attempts fail, contact Customer Technical Support. " Repeat testing for any cancelled tests. " No action is required if your laboratory has not observed the events listed above ESOLUTION: "A Beckman Coulter representative will schedule the modification installation when it is available. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support: " From our website: http://www.beckmancoulter.com

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    1 system