Beckman Coulter DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-1664-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-04-30. When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) o
| Recall number | Z-1664-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-03-27 |
| Classified | 2025-04-24 |
| Reported by FDA | 2025-04-30 |
| Quantity | 370 units |
| UPC / GTIN / UDI-DI | 15099590732103 |
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Reason for recall
When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay 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-1664-2025. 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.