BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1235-2026 · Initiated December 23, 2025

    Recall

    Recall Number
    Z-1235-2026
    Event Number
    98207
    Firm
    Beckman Coulter, Inc.
    FEI Number
    3000203293
    Product Code
    PER
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    December 23, 2025
    Posted
    February 2, 2026
    Address
    11800 Sw 147th Ave, Miami, FL, 33196-2500

    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.

    Action

    On 12/23/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) To mitigate the risk of contact between the dispense probe and the tube bottom, utilize CellMek SPS output tubes distributed by Beckman Coulter. 2) For absolute count assays, use the CellMek SPS on-board counting bead feature. Do not add counting beads to samples manually after preparation with CellMek SPS. 3) Share the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 4) Firm recommends posting this letter on or near the affected instruments. 5) Complete and return the response form. Firm will perform an on-site service modification to update your instrument software to correct this issue. If you have any questions regarding this notice, please contact the firm's Customer Support Center: http://www.beckman.com, (800) 369-0333

    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