CellMek SPS Sample Preparation System — Class II medical device recall Z-0412-2026
Ongoing recall by Beckman Coulter, Inc., reported 2025-11-05, distributed nationwide. Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instruc
| Recall number | Z-0412-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Miami, FL, United States |
| Recall initiated | 2025-09-08 |
| Classified | 2025-10-30 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, DE, ES, FR, GB, GR, HK, IE, IL, IT, JP, KR, MA, MX, NL, PL, PT, ZA |
| Quantity | 108 units |
| Reason classes | software |
| Model numbers | C44603 |
Product
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
Reason for recall
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.
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-0412-2026. 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.