Beckman Coulter CellMek SPS Sample Preparation System recalled for software error causing sample loss
A software error in the Beckman Coulter CellMek SPS Sample Preparation System (model C44603, software version 2.3.90.0) causes samples to be dispensed incorrectly, potentially damaging the instrument and losing 60–100 microliters of sample fluid. This could lead to inaccurate test results and incorrect patient care decisions.
From the FDA notice · Read the official notice ↗ · All Beckman Coulter recalls
What to do
- If you operate this system, stop using it immediately and contact Beckman Coulter for instructions
- Do not run patient samples through the affected device until you receive guidance
- Verify your system's software version matches 2.3.90.0 and UDI-DI 15099590750312
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- CellMek SPS Sample Preparation System, REF: C44603, with software
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 50
- Illnesses reported
- None reported
- Manufactured in
- 11800 Sw 147th Ave, N/A, Miami, FL, United States
- Classification
- Class II
- Recall number
- Z-1235-2026
In the FDA's words
- Description
- 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. UDI-DI: 15099590750312. Software Version 2.3.90.0 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. Affected quantity: 50
- Hazard
- 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.
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