DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-2735-2024
Ongoing recall by Beckman Coulter, Inc., reported 2024-09-04, distributed nationwide. When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is runnin
| Recall number | Z-2735-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-05-22 |
| Classified | 2024-08-27 |
| Reported by FDA | 2024-09-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BH, BR, CH, CZ, DE, EG, ES, FR, GB, HR, HU, IE, IL, IT, NL, NZ, PL, PT, SK, TW, ZA |
| Quantity | 183 analyzers |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 15099590732103 |
| Model numbers | C11137 |
Product
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Reason for recall
When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.
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-2735-2024. 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.