DxI 9000 Access Immunoassay Analyzer C11137 — Class II medical device recall Z-1996-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-07-02, distributed nationwide. Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspira
| Recall number | Z-1996-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-05-07 |
| Classified | 2025-06-20 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CH, CZ, DE, DZ, ES, FR, GB, HR, HU, IE, IL, IN, IT, KR, NZ, OM, PL, PT, SE, SG, SK, TW |
| 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, 300179 and 221 more |
Product
DxI 9000 Access Immunoassay Analyzer C11137
Reason for recall
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
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-1996-2025. 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.