Lower riskMedical device recall · FDA · Published December 23, 2025
Beckman Coulter CellMek SPS Sample Prep System Software Error Risk
Beckman Coulter recalls CellMek SPS Sample Preparation System with software error causing sample loss and potential incorrect diagnosis. Affected units have specific model and software version.
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.
“Beckman Coulter CellMek SPS Sample Prep System Software Error Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50360-beckman-coulter-cellmek-sps-sample-prep-system-software-error-risk. Based on FDA recall #Z-1235-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1235-2026%22&limit=1).
The FDA announced on 2025-12-23 that Beckman Coulter, Inc. is recalling the CellMek SPS Sample Preparation System due to a software error causing sample loss and potential incorrect diagnosis. Owners should contact the company for remedy details.
How to tell if you have it
Brand: Beckman Coulter
Product: CellMek SPS Sample Preparation System
REF: C44603
Software Version: 2.3.90.0
UDI-DI: 15099590750312
The hazard
A software error causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid lines and result in sample loss or spillage. This may lead to the unintentional removal of 60-100 microliters from the final sample, potentially causing incorrect diagnosis or patient management.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since 2017-06-20. Recent brand recalls include Beckman Coulter DxC 500i Modules with Software 1.5 (2026-07-15), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 (2026-06-26), and Beckman Coulter Access Total T4 Calibrator Recall (2026-03-16). Other recent recalls of similar products include Beckman Coulter REMISOL Advance Software Issue (2026-04-29), Beckman Coulter Emit 2000 Quinidine Assay Recall (2026-07-13), and Medline Namic Preceptor Manifold Recall (2026-03-24).
How to tell if you have this one
Check for the CellMek SPS Sample Preparation System with software version 2.3.90.0. The product has a UDI-DI number 15099590750312.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your CellMek SPS system. If it is 2.3.90.0, it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Illinois, Massachusetts, Missouri, Oregon, Washington.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1235-2026 (December 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1235-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.