DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-1326-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-03-19, distributed nationwide. The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing.
| Recall number | Z-1326-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-11-13 |
| Classified | 2025-03-12 |
| Reported by FDA | 2025-03-19 |
| Distributed | Nationwide (US) |
| Quantity | 245 units |
| UPC / GTIN / UDI-DI | 15099590732103 |
| Serial numbers | 300116, 300117, 300123, 300124, 300126, 300128, 300129, 300130, 300131, 300132, 300133, 300134, 300135, 300136, 300137, 300138, 300139, 300141, 300142, 300143, 300144, 300145, 300147, 300148, 300149 and 220 more |
| Model numbers | C11137 |
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Reason for recall
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause 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-1326-2025. 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.