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

FDA Recall #Z-2267-2025 — Class II — June 25, 2025

Recall #Z-2267-2025 Date: June 25, 2025 Classification: Class II Status: Ongoing

Product Description

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

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.

Recalling Firm

Beckman Coulter, Inc. — Chaska, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1 system

Distribution

Worldwide distribution - US Nationwide.

Code Information

UDI-DI: 15099590369231; Serial Numbers: 608109

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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