DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Published August 13, 2025 · Recall initiated: June 25, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter, Inc.
- Distributor
- Worldwide distribution - US Nationwide.
- Lot
- UDI-DI: 15099590369231; Serial Numbers: 608109
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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