FDA Medical devices recall ·
CellMek SPS Sample Preparation System recall
- Recall number
- Z-1235-2026
- Date
- (initiated December 23, 2025)
- Company / brand
- Beckman Coulter, Inc.
11800 Sw 147th Ave, Miami, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 50
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CellMek SPS Sample Preparation System, REF: C44603, with software
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 15099590750312. Software Version 2.3.90.0
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.
States: Alabama Delaware Illinois Massachusetts Missouri Oregon Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1235-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.