BEUDAMED
    FDA Recall Open, Classified

    DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

    Recall: Z-0107-2024 · Initiated September 12, 2023

    Recall

    Recall Number
    Z-0107-2024
    Event Number
    93023
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 12, 2023
    Posted
    October 12, 2023
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    Description

    DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

    Reason

    The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.

    Action

    Beckman Coulter notified its consignees on 09/12/2023 via letter. The notice explained the issue, risk, and consignees were advised to perform a retrospective review of all results that were generated on a DxI 9000 analyzer that is connected to a host system (laboratory information system or middleware). Current customers should perform one of the following: Option 1: Disconnect the DxI 9000 Access Immunoassay Analyzer from the host system. You may continue ordering tests through the analyzer console. Option 2: Prevent the host system from downloading test orders or sending new information updates to the analyzer. Beckman Coulter will release system software version 1.15.2, which prevents reporting an erroneous test result. Test results will still be delayed when the DxI 9000 Access Immunoassay Analyzer may incorrectly identify samples.

    Distribution

    Worldwide - US Nationwide distribution in the state of Florida, and the countries of Croatia, Czechia, France, Germany, Ireland, Italy, Netherlands, New Zealand, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.

    Quantity

    36 units