DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-1529-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-04-16. Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying pati
| Recall number | Z-1529-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-07-12 |
| Classified | 2025-04-04 |
| Reported by FDA | 2025-04-16 |
| Countries outside the US | AU, CZ, DE, ES, FR, GB, HR, IE, IL, IT, NL, NZ, ZA |
| Quantity | 30 ous |
| UPC / GTIN / UDI-DI | 15099590732103 |
| Lot 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, 300152, 300153, 300154, 300155, 300156 |
| Model numbers | C11137 |
Product
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids
Reason for recall
Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.
Machine access
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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.