DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-1387-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-03-26, distributed nationwide. Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interfac
| Recall number | Z-1387-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-02-06 |
| Classified | 2025-03-17 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 80 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 15099590732103 |
| Serial numbers | 300158, 300161, 300164, 300167, 300169, 300175, 300178, 300179, 300182, 300183, 300185, 300189, 300194, 300197, 300201, 300202, 300204, 300210, 300216, 300217, 300218, 300220, 300224, 300225, 300233 and 55 more |
| Model numbers | C11137 |
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
Reason for recall
Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting 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-1387-2025. 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.