Beckman Coulter DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-3180-2024
Ongoing recall by Beckman Coulter, Inc., reported 2024-09-25, distributed nationwide. Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in t
| Recall number | Z-3180-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-07-10 |
| Classified | 2024-09-19 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BH, BR, CH, CZ, DE, EG, ES, FR, GB, HR, HU, IE, IL, IT, NL, NZ, PL, PT, SE, SK, TW, ZA |
| Quantity | 170 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 15099590230623 |
| Serial numbers | 300116, 300117, 300118, 300123, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300137, 300138, 300139, 300141, 300142, 300143, 300145, 300147, 300148, 300149, 300150, 300151 and 145 more |
| Model numbers | C11137, C21510 |
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
Reason for recall
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of 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-3180-2024. 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.