Company: Beckman Coulter, Inc
Date of Enforcement Report: 2/2/2026
Class: II
PRODUCT:
CellMek SPS Sample Preparation System, REF: C44603, with software
Recall Number:
Z-1235-2026
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Beckman Coulter, Inc
VOLUME:
50
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.
