Use cautionMedical device recall · FDA · Published September 8, 2025
Beckman Coulter CellMek SPS Software Error May Cause Incorrect Diagnosis
Beckman Coulter recalls CellMek SPS Sample Preparation System software versions 2.2.122.0 and prior with incorrect dead volumes that may lead to incorrect diagnosis or treatment errors.
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.
“Beckman Coulter CellMek SPS Software Error May Cause Incorrect Diagnosis.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51388-beckman-coulter-cellmek-sps-software-error-may-cause-incorrect-diagnosis. Based on FDA recall #Z-0412-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0412-2026%22&limit=1).
The FDA announced on September 8, 2025, that Beckman Coulter, Inc. is recalling the CellMek SPS Sample Preparation System due to incorrect dead volume listings and software errors that may lead to incorrect diagnoses. The agency issued recall number Z-0412-2026 for the voluntary Class II action.
The device instructions for use list incorrect dead volumes, and the software does not rock Cassette E used with specific tubes. This may lead to incorrect diagnosis or error in patient management or treatment.
Context
GovInfoNow's records show Beckman Coulter has 132 other recalls on record since June 20, 2017. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 (July 15, 2026), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026), and Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026). Other recent recalls of similar products include Beckman Coulter REMISOL Advance Software Issue (April 29, 2026), Beckman Coulter DxC 700 AU Recall (January 30, 2026), and HardyDisk AST Cefiderocol 30μg FDC30 (June 8, 2026).
How to tell if you have this one
Check for software versions 2.2.122.0 and prior or IFU revisions AD and prior. Affected units have serial numbers between BE43003 and BJ18014, manufactured from December 2021 to April 2025.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your CellMek SPS software version; if it is 2.2.122.0 or earlier, it is affected.
Review Instructions for Use
Check if your instructions for use are revisions AD or earlier; affected units include Cassette E.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 15 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN, MA, ME, MI, MN, MO, NY, OR, TN, UT, WA and the countries Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Israel, Italy,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, Florida, Illinois, Indiana, Maine, Massachusetts, Michigan, Minnesota, Missouri, New York, Oregon, Puerto Rico, Tennessee, Utah, Washington.
Recall timeline
FDA published this recall 58 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-0412-2026 (September 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0412-2026 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.