Dxl 9000 Access Immunoassay Analyzer — Class II medical device recall Z-2414-2024
Ongoing recall by Beckman Coulter, Inc., reported 2024-07-31, distributed nationwide. The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold cont
| Recall number | Z-2414-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-06-04 |
| Classified | 2024-07-23 |
| Reported by FDA | 2024-07-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CH, CN, CZ, DE, EG, ES, FR, GB, HR, HU, IE, IL, IT, NL, NZ, PL, PT, SK, TW, ZA |
| Quantity | 143 devices |
| UPC / GTIN / UDI-DI | 15099590732103 |
| Serial numbers | 300116, 300117, 300123, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300137, 300138, 300139, 300140, 300141, 300142, 300143, 300144, 300145, 300146, 300147, 300148, 300149 and 118 more |
| Model numbers | C11137 |
Product
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Reason for recall
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed 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-2414-2024. 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.