Beckman Coulter, Inc. — DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
⚠️ 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 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
- Lot code
- UDI-DI: 15099590369231; Serial Numbers: 608109
Additional details
UDI-DI: 15099590369231; Serial Numbers: 608109
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 system.
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