BEUDAMED
    FDA Enforcement Class II Ongoing

    CellMek SPS Sample Preparation System, REF: C44603, with software

    Recall: Z-1235-2026 · Reported February 11, 2026

    Enforcement

    Recall Number
    Z-1235-2026
    Event ID
    98207
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2026
    Initiation Date
    December 23, 2025
    Classification Date
    February 2, 2026
    Address
    11800 Sw 147th Ave, N/A, Miami, FL, 33196-2500, United States

    Description

    CellMek SPS Sample Preparation System, REF: C44603, with software

    Reason

    Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.

    Code Info

    UDI-DI: 15099590750312. Software Version 2.3.90.0

    Distribution

    Worldwide - US Nationwide distribution in the states of MO, WA, MA, IL, AL, OR, IL and the countries of AB, BE, ES, FR, NL, ON, DE, AT, VIC, AU, GB, SK, MX, CH.

    Quantity

    50