CellMek SPS Sample Preparation System, REF: C44603, with software
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 23, 2025 |
| Reported | February 11, 2026 |
| Recalling firm | Beckman Coulter, Inc. |
| Country / region | United States FL |
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.
Affected products
- CellMek SPS Sample Preparation System, REF: C44603, with software
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