Beckman Coulter UniCel DxI 800 — Class II medical device recall Z-0429-2026
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-0429-2026 |
|---|---|
| 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 | 657 units |
| UPC / GTIN / UDI-DI | 15099590265373, 16954701000412 |
| Serial numbers | 610415, 610416, 610418, 610419, 610423, 610424, 610425, 610426, 610430, 610431, 610432, 610433, 610434, 610435, 610439, 610440, 610441, 610442, 610443, 610444, 610445, 610452, 610453, 610454, 610455 and 475 more |
| Model numbers | 973100, A71456 |
Product
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; 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-0429-2026. 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.