BEUDAMED
    FDA Recall Open, Classified

    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

    Recall: Z-1913-2025 · Initiated April 23, 2025

    Recall

    Recall Number
    Z-1913-2025
    Event Number
    96762
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    JLW
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    April 23, 2025
    Posted
    June 5, 2025
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    Description

    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

    Reason

    A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

    Action

    An "URGENT MEDICAL DEVICE RECALL (UMDR)" notification letter dated 4/16/2025 was sent to customers. ACTION: If your laboratory has experienced the red system event and it is not resolved by initializing the analyzer, contact your Beckman Coulter representative and schedule a service visit. RESOLUTION: Beckman Coulter will release a modification for this issue. Your service 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 Customer Support Center: From our website: http://www.beckmancoulter.com

    Distribution

    Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain and Northern Irland, Oman, Algeria, Czechia, Korea, Public of, Slovakia, Croatia, Cote d'lvoire, Australia, Ireland, Taiwan, Province of China, New Zealand, Austria, Hungary, Brazil, Israel, Portugal.

    Quantity

    231 units