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Medical Device

CellMek SPS Sample Preparation System, REF: C44603, with software

Recall date: 2026-02-11 · Source: FDA_DEVICE
Brand / Firm
Beckman Coulter, Inc.
Product
CellMek SPS Sample Preparation System, REF: C44603, with software
Reason for recall
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.
Units affected
50
Description
CellMek SPS Sample Preparation System, REF: C44603, with software
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