Z-1235-2026 Class II Ongoing
FDA device recall Z-1235-2026 was initiated by Beckman Coulter, Inc. on December 23, 2025 and is designated Class II. 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 lin… The recall status is ongoing. Affected quantity: 50.
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2026
- Initiation Date
- December 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50
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.
Distribution Pattern
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