FDA DevicesClass II
CellMek SPS Sample Preparation System, REF: C44603, with software
Published: February 11, 2026Recall ID: Z-1235-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
CellMek SPS Sample Preparation System, REF: C44603, with software
Additional Source Details
| Field | Value |
|---|---|
| City | Miami |
| State | FL |
| Event id | 98207 |
| Address 1 | 11800 Sw 147th Ave |
| Address 2 | N/A |
| Code info | UDI-DI: 15099590750312. Software Version 2.3.90.0 |
| Postal code | 33196-2500 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 50 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251223 |
| Initial firm notification | Letter |
| Center classification date | 20260202 |
Overview
- Recalling FirmBeckman Coulter, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.