FDA recall Z-2268-2025

Beckman Coulter, Inc. · Class II · device

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2025-06-25
Report date: 2025-08-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2268-2025