CellMek SPS Sample Preparation System, REF: C44603, with… recallZ-1235-2026 · Beckman Coulter, Inc. · initiated Dec 23, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software change control
What the company is doing
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
Recall details
- Recall number
- Z-1235-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 23, 2025
- Posted by the FDA
- Feb 2, 2026
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 50
- Product code
- PER
- 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.
Product description
CellMek SPS Sample Preparation System, REF: C44603, with software
Code information (models, lots, serial numbers)
UDI-DI: 15099590750312. Software Version 2.3.90.0
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cellmek C44603Beckman Coulter, Inc. · Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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