FDA Recall: Software anomaly causes increased PnP motion errors

Company: Beckman Coulter, Inc.
Date of Enforcement Report: 8/5/2025
Class: II

PRODUCT

Recall Number:

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.

RECALLING FIRM/MANUFACTURER:

Beckman Coulter, Inc.

VOLUME:

DISTRIBUTION:

Worldwide distribution – US Nationwide.