CellMek SPS Sample Preparation System, REF: C44603, with software
FDA Recall #Z-1235-2026 — Class II — December 23, 2025
Product Description
CellMek SPS Sample Preparation System, REF: C44603, with software
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.
Recalling Firm
Beckman Coulter, Inc. — Miami, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
UDI-DI: 15099590750312. Software Version 2.3.90.0
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated