BEUDAMED
    FDA Recall Open, Classified

    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

    Recall: Z-1387-2025 · Initiated February 6, 2025

    Recall

    Recall Number
    Z-1387-2025
    Event Number
    96268
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 6, 2025
    Posted
    March 17, 2025
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    Description

    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

    Reason

    Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.

    Action

    An URGENT MEDICAL DEVICE RECALL notification letter was sent to customers beginning on 2/6/25. Beckman Coulter has determined that a DxI 9000 Access Immunoassay Analyzer containing tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. If the analyzer experiences the issue described above, it can lead to the analyzer entering the red, or Stopped, system status due to Reagent Storage and Tip Stocker "axis is out of tolerance" errors. Any in process tests that require addition of reagent at the time of the error are cancelled. There could be a delay in reporting patient test results to the physician. If the error occurs: 1. Confirm that the DxI 9000 Access Immunoassay Analyzer is in either the Paused or Stopped system state. 2. Select the System state button in the lower left corner of the user interface. 3. Select Initialize. When initialization is complete, the analyzer returns to the green, or Running, state. If your laboratory has experienced the issue and it is not resolved by initializing the analyzer, contact your Beckman Coulter representative and schedule a service visit. Beckman Coulter has identified the root cause of this issue and is no longer distributing affected TSI-RSI boards. A Beckman Coulter service representative will schedule a visit to replace any affected TSI-RSI boards on your DxI 9000 Access Immunoassay Analyzer. 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. I

    Distribution

    Worldwide - US Nationwide distribution in the states of FL, TX, WA.

    Quantity

    80 units