BEUDAMED
    FDA Enforcement Class II Ongoing

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

    Recall: Z-2544-2024 · Reported August 21, 2024

    Enforcement

    Recall Number
    Z-2544-2024
    Event ID
    94841
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2024
    Initiation Date
    May 22, 2024
    Classification Date
    August 9, 2024
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037, United States

    Description

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

    Reason

    The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.

    Code Info

    Software versions 1.17 and below, UDI-DI 15099590732103.

    Distribution

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

    Quantity

    183 devices