Beckman Coulter DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-1115-2025
Completed recall by Beckman Coulter, Inc., reported 2025-02-12, distributed nationwide. A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a de
| Recall number | Z-1115-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-01-03 |
| Classified | 2025-02-06 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BR, CH, CN, DE, ES, FR, GB, HR, HU, IE, IN, IT, NZ, PT, SK, TW |
| Quantity | 61 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 15099590732103 |
| Serial numbers | 300168, 300169, 300170, 300171, 300172, 300173, 300174, 300175, 300176, 300177, 300178, 300179, 300180, 300181, 300182, 300183, 300184, 300185, 300186, 300187, 300188, 300189, 300190, 300191, 300192 and 36 more |
| Model numbers | C11137 |
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Reason for recall
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient 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-1115-2025. 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.