CellMek SPS Sample Preparation System, REF: C44603, with software
Pending LLM rewrite. Source: FDA_DEVICE Z-1235-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- CellMek SPS Sample Preparation System, REF: C44603, with software
- Manufacturer
- Beckman Coulter, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 15099590750312. Software Version 2.3.90.0
Distribution
Distributed nationwide across the United States.
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