FDA Enforcement
Class II
Ongoing
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Recall: Z-2270-2025
·
Reported August 13, 2025
Enforcement
- Recall Number
- Z-2270-2025
- Event ID
- 97162
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Beckman Coulter, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 13, 2025
- Initiation Date
- June 25, 2025
- Classification Date
- August 5, 2025
- Address
- 1000 Lake Hazeltine Dr, N/A, Chaska, MN, 55318-1037, United States
Description
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
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 Info
UDI-DI: 15099590369248; Serial Numbers: 902101
Distribution
Worldwide distribution - US Nationwide.
Quantity
1 system