BEUDAMED
    FDA Enforcement Class II Ongoing

    Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

    Recall: Z-1025-2026 · Reported January 14, 2026

    Enforcement

    Recall Number
    Z-1025-2026
    Event ID
    98070
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 14, 2026
    Initiation Date
    November 26, 2025
    Classification Date
    January 6, 2026
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037, United States

    Description

    Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

    Reason

    Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.

    Code Info

    A71460: UDI 15099590369224 A71461: UDI 15099590369248 A30260: UDI 15099590341602

    Distribution

    Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cabo Verde, Canada, Chile, China, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Egypt, El Salvador, Eswatini, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Moldova, Republic of, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam, and Zimbabwe.

    Quantity

    1272 units