DxI 600 Access Immunoassay Analyzer W/Dual Gantry — Class II medical device recall Z-2270-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-08-13, distributed nationwide. Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running soft
| Recall number | Z-2270-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-06-25 |
| Classified | 2025-08-05 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Quantity | 1 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 15099590369248 |
| Serial numbers | 902101 |
| Model numbers | A71461 |
Product
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Reason for recall
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
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-2270-2025. 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.