Recall
FDAHealthJune 25, 2025

Beckman Coulter, Inc. — DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 25, 2025

Worldwide distribution - US Nationwide.

What's affected?

Product
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Lot code
UDI-DI: 15099590369248; Serial Numbers: 902101

Additional details

UDI-DI: 15099590369248; Serial Numbers: 902101

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 1 system.

View original FDA notice →

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