FDA-Device2026-02-11Class IIPROCESSING DEFECT

Beckman Coulter CellMek SPS Sample Preparation System recalled for software error causing sample loss

OTHERNationwide distribution

Stop using affected Beckman Coulter CellMek systems

A software error in the Beckman Coulter CellMek SPS Sample Preparation System (model C44603, software version 2.3.90.0) causes samples to be dispensed incorrectly, potentially damaging the instrument and losing 60–100 microliters of sample fluid. This could lead to inaccurate test results and incorrect patient care decisions.

If you operate this system, stop using it immediately and contact Beckman Coulter for instructions
Do not run patient samples through the affected device until you receive guidance
Verify your system's software version matches 2.3.90.0 and UDI-DI 15099590750312

Hazard

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.

Sold states

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.

Affected count

Manufactured in

11800 Sw 147th Ave, N/A, Miami, FL, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1235-2026

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