Beckman Coulter, Inc. recalls DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456

Recall date

June 25, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2268-2025

FDA classification

Class II

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

Worldwide distribution - US Nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456