Goat Feed · MAUDE

    MAUDE adverse event: Beckman Coulter, Inc - UNICEL DXI 800 ACCESS IMMUNO ANALY

    Reported to the FDA Oct 29, 2026 (event Feb 13, 2025). The FDA publishes these reports weeks after receipt. The customer reported a Sample Presentation Unit (SPU) motion error on a UniCel DxI 800 Access Immunoassay Analyzer, Product Number 973100, Serial Number (b)(6). As reported, patie

    Back to the daily feed
    MAUDE
    notable

    Other items reviewed by the Blue Goat team.

    Need help acting on this?

    Talk to Blue Goat Cyber

    Penetration testing, SBOM, threat modeling, and 524B submission support for MedTech.