DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-1388-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-03-26, distributed nationwide. the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing
| Recall number | Z-1388-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-02-05 |
| Classified | 2025-03-17 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 206 units |
| UPC / GTIN / UDI-DI | 15099590732103 |
| Serial numbers | 300116-300117, 300123-300124, 300126, 300128-300139, 300141-300145, 300147, 300158, 300160-300164, 300166-300179, 300181-300183, 300186, 300188-300195, 300197-300207, 300209-300250, 300252, 300256, 300258-300259, 300261, 300263, 300264, 300266-300277, 300279-300290, 300291, 300293-300299, 300300-300309 and 1 more |
| Model numbers | C11137 |
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Reason for recall
the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays 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-1388-2025. 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.