Medical Device Recall: DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Beckman Coulter, Inc. · June 25, 2025
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide.
States Affected
NATIONWIDE
Quantity Affected
177 systems
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2271-2025
Status: ongoing
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