DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-1913-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-06-11, distributed nationwide. A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being
| Recall number | Z-1913-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-04-23 |
| Classified | 2025-06-05 |
| Reported by FDA | 2025-06-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CH, CN, CZ, DE, DZ, ES, FR, GB, HR, HU, IE, IL, IN, IT, KR, NZ, OM, PL, PT, SG, SK, TW |
| Quantity | 231 units |
| Reason classes | potency, software |
| UPC / GTIN / UDI-DI | 15099590732103 |
| Serial numbers | 300116, 300124, 300126, 300128, 300132, 300136, 300138, 300144, 300145, 300148, 300150, 300153, 300154, 300155, 300156, 300157, 300158, 300161, 300166, 300168, 300171, 300174, 300175, 300178, 300182 and 206 more |
| Model numbers | C11137 |
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Reason for recall
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
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-1913-2025. 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.