CellMek SPS Sample Preparation System recall (Beckman Coulter, Inc.)

Medical deviceClass IIOngoing

Summary: Beckman Coulter, Inc. is recalling CellMek SPS Sample Preparation System, REF: C44603, with software. 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.

What is being recalled

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

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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 named: Alabama, Illinois, Massachusetts, Missouri, Oregon, Washington)

How to tell if yours is affected

UDI-DI: 15099590750312. Software Version 2.3.90.0

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Beckman Coulter, Inc. · all medical device recalls · recalls from December 2025

Official FDA record