Medical Device Recall: CellMek SPS Sample Preparation System, REF: C44603, with software
Beckman Coulter, Inc. · December 23, 2025
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.
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.
States Affected
NATIONWIDE
Quantity Affected
50
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1235-2026
Status: ongoing
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