Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603, with sof
Recalled Product
CellMek SPS Sample Preparation System, REF: C44603, with software
Hazard / Issue
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.
Issued by
FDA
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