Beckman Coulter, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2267-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

Product Classification:

Class II

Date Initiated: June 25, 2025

Date Posted: August 13, 2025

Recall Number: Z-2267-2025

Event ID: 97162

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.

Status: Ongoing

Product Quantity: 1 system

Code Information:

UDI-DI: 15099590369231; Serial Numbers: 608109

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated