BEUDAMED
    FDA Enforcement Class II Completed

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

    Recall: Z-1115-2025 · Reported February 12, 2025

    Enforcement

    Recall Number
    Z-1115-2025
    Event ID
    96103
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    February 12, 2025
    Initiation Date
    January 3, 2024
    Classification Date
    February 6, 2025
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037, United States

    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.

    Code Info

    UDI/DI 15099590732103, serial numbers: 300208, 300201, 300184, 300185, 300169, 300225, 300175, 300172, 300221, 300209, 300211, 300212, 300213, 300214, 300215, 300210, 300174, 300226, 300204, 300216, 300217, 300170, 300220, 300176, 300188, 300199, 300200, 300177, 300222, 300224, 300173, 300181, 300202, 300191, 300223, 300171, 300186, 300190, 300203, 300178, 300195, 300189, 300198, 300227, 300228, 300168, 300194, 300205, 300206, 300207, 300197, 300218, 300179, 300182, 300192, 300219, 300193, 300183, 300180, 300187, 300196.

    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