Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603, with software

Recall date

December 23, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1235-2026

FDA classification

Class II

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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