BEUDAMED
    FDA Enforcement Class II Ongoing

    DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

    Recall: Z-0982-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-0982-2024
    Event ID
    93724
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2024
    Initiation Date
    November 21, 2023
    Classification Date
    February 5, 2024
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037, United States

    Description

    DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

    Reason

    There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or <) to derive a calculated test as part of result reporting; 4) Reserve volume is enabled and the assay LIS code is not the same as the assay Test ID. These issues could potentially lead to erroneous results or delay reporting results for multiple analytes.

    Code Info

    UDI/DI 15099590732103, Serial Numbers: 300116, 300117, 300118, 300123, 300127, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300138, 300139, 300137, 300140, 300142, 300141, 300144, 300143, 300145, 300148 300146, 300147, 300149, 300150, 300151, 300152, 300155, 300153, 300154, 300156, 300158, 300160, 300163, 300161, 300162, 300164, 300167, 300170, 300169, 300171, 300168, 300166, 300172, 300176, 300173, 300178, 300181, 300179, 300183, 300182, 300188, 300189, 300190, 300191, 300192, 300195, 300196, 300193, 300194, 300197, 300199, 300198, 300201, 300200, 300202, 300203, 300205, 300204 300207, 300206, 300208, 300209, 300212, 300210, 300211, 300213, 300214, 300215, 300217, 300216, 300220, 300218, 300219, 300221, 300223, 300224, 300222, 300227, 300228, 300229, 300231, 300230, 300235, 300236, 300234, 300237, 300232, 300239, 300233, 300238, 300240, 300243, 300241, 300242, 300247, 300246, 300249, 300253, 300244, 300250, 300252, 300248, 300251, 300256, 300257, 300254, 300258, 300255, 300259, 300260, 300261, 300264, 300263, 300262; running software version 1.16 or prior

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Croatia, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

    Quantity

    128 analyzers