Beckman Coulter Dxl 9000 Access Immunoassay Analyzer — Class II medical device recall Z-0025-2025
Ongoing recall by Beckman Coulter, Inc., reported 2024-10-16, distributed in FL, GA, IN, KS, NH, NJ, OK, PA…. When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to a
| Recall number | Z-0025-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-04-18 |
| Classified | 2024-10-07 |
| Reported by FDA | 2024-10-16 |
| Distributed | FL, GA, IN, KS, NH, NJ, OK, PA, TX |
| 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, SE, SK, TW, ZA |
| Quantity | 164 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 15099590230623 |
| Serial numbers | 300182, 300192, 300195, 300205, 300206, 300207, 300223, 300227, 300228, 300234, 300260, 300266, 300284, 300285, 300286, 300291, 300292, 300294 |
| Model numbers | C11137 |
Product
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An 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
When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.
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-0025-2025. 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.