FDA-Device2025-08-13Class II
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Beckman Coulter, Inc.
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.
Sold states
Worldwide distribution - US Nationwide.
Affected count
451 systems
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2268-2025Don't want to check this manually?
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