BEUDAMED
    FDA Enforcement Class II Ongoing

    DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

    Recall: Z-2735-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2735-2024
    Event ID
    94840
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2024
    Initiation Date
    May 22, 2024
    Classification Date
    August 27, 2024
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037, United States

    Description

    DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

    Reason

    When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.

    Code Info

    Software versions 1.17.0 or below, UDI-DI 15099590732103.

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, FL, GA, IN, KS, ME, NH, NJ, OK, PA, TX, and WA. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom of Great Britain and Northern Ireland.

    Quantity

    183 analyzers