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Recall Observatory FDA recall evidence

Device product

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

Z-2267-2025

June 25, 2025

Class II

Product summary

Firm
Beckman Coulter, Inc.
Event
Event 97162
Status
Ongoing
Classification
Class II
Quantity
1 system
Official record key
device-enforcement:Z-2267-2025

Official wording

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.

Code information: UDI-DI: 15099590369231; Serial Numbers: 608109

Distribution pattern: Worldwide distribution - US Nationwide.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software versions 5.7 and up faced incorrect