Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System
- Recalling company
- Beckman Coulter, Inc.
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 23, 2025
- Reported
- Feb 11, 2026
- 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.
- Status
- Ongoing
- Quantity
- 50
- Lot / codes
- UDI-DI: 15099590750312. Software Version 2.3.90.0
- Company location
- Miami, FL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1235-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1235-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.