Beckman Coulter, Inc. — DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 25, 2025
Worldwide distribution - US Nationwide.
What's affected?
- Product
- DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
- Lot code
- UDI-DI: 15099590369248; Serial Numbers: 902101
Additional details
UDI-DI: 15099590369248; Serial Numbers: 902101
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 system.
Get Health recall alerts
Delivered to your inbox. Free. No account required.