Device product
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Z-2270-2025
Product summary
- Event
- Event 97162
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 system
- Official record key
device-enforcement:Z-2270-2025
Official wording
Reason: 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.
Code information: UDI-DI: 15099590369248; Serial Numbers: 902101
Distribution pattern: Worldwide distribution - US Nationwide.
Derived failure modes
-
Device software or design
software versions 5.7 and up faced incorrect