Beckman Coulter, Inc. — CellMek SPS Sample Preparation System, REF: C44603, with software
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 23, 2025
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.
What's affected?
- Product
- CellMek SPS Sample Preparation System, REF: C44603, with software
- Lot code
- UDI-DI: 15099590750312. Software Version 2.3.90.0
Additional details
UDI-DI: 15099590750312. Software Version 2.3.90.0
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 50.
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