Beckman Coulter UniCel DxI 600 — Class II medical device recall Z-0428-2026
Ongoing recall by Beckman Coulter, Inc., reported 2025-11-12. An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-
| Recall number | Z-0428-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-10-01 |
| Classified | 2025-11-04 |
| Reported by FDA | 2025-11-12 |
| Quantity | 80 units |
| UPC / GTIN / UDI-DI | 15099590341602, 15099590369224 |
| Serial numbers | 902504, 902505, 902506, 902507, 902508, 902509, 902510, 902511, 902512, 902513, 902514, 902515, 902516, 902517, 902518, 902519, 902520, 902521, 902522, 902523, 902524, 902525, 902526, 902527, 902528 and 56 more |
| Model numbers | A30260, A71460 |
Product
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Reason for recall
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.
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-0428-2026. 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.