DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-0216-2026
Ongoing recall by Beckman Coulter, Inc., reported 2025-10-29, distributed nationwide. Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clin
| Recall number | Z-0216-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-09-19 |
| Classified | 2025-10-21 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 571 units |
| Reason classes | software |
| 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 475 more |
| Model numbers | C11137 |
Product
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Reason for recall
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
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.