Beckman Coulter DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-2544-2024
Ongoing recall by Beckman Coulter, Inc., reported 2024-08-21, distributed nationwide. The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer
| Recall number | Z-2544-2024 |
|---|---|
| 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 | 2024-08-09 |
| Reported by FDA | 2024-08-21 |
| 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 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 15099590732103 |
| Model numbers | C11137 |
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Reason for recall
The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and 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-2544-2024. 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.