CellMek SPS Sample Preparation System — Class II medical device recall Z-1235-2026
Ongoing recall by Beckman Coulter, Inc., reported 2026-02-11, distributed nationwide. Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes
| Recall number | Z-1235-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Miami, FL, United States |
| Recall initiated | 2025-12-23 |
| Classified | 2026-02-02 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 50 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 15099590750312 |
| Model numbers | C44603 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1235-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.