—#217890

Product

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

FDA product code: PER — Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: UDI-DI: 15099590750312. Software Version 2.3.90.0

Why it was recalled

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.

Root cause (FDA determination)

Software change control

Action the firm took

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

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 11800 Sw 147th Ave, Miami, Florida 33196-2500

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-12-23
Posted by FDA: 2026-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217890. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.