Health product recall

UniCel DxI 600 & 800 Systems

Last updated

Summary

Product
UniCel DxI 600 & 800 Systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

UniCel DxI 600 Access Immunoassay Analyzer

902386

A30260

UniCel DxI 600 Access Immunoassay Analyzer

902624

A30260

UniCel DxI 600 Access Immunoassay Analyzer

902385

A30260

UniCel DxI 600 Access Immunoassay Analyzer

902622

A30260

UniCel DxI 600 Access Immunoassay Analyzer

902475

A30260

DxI 600 Access Immunoassay W/Spot B

More than 10 numbers, contact manufacturer.

A71460

UniCel DxI 800 Access Immunoassay Analyzer

609576

973100

Issue

Beckman identified an issue on UniCel DxI 600 & 800 Systems with linear slide pnp gantries running software versions 5.7 and up. During installs or upgrades, the Beckman identified an issue on UniCel DxI 600 & 800 Systems with linear slide pnp gantries running software versions 5.7 and up. During installs or upgrades, the pnp xmotor current incorrectly resets to 1.5a (instead of the required 2.0a) because the software overwrites the factory setting, causing increased pnp motion errors. current incorrectly resets to 1.5a (instead of the required 2.0a) because the software overwrites the factory setting, causing increased pnp motion errors.

Recall start date: June 18, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Beckman Coulter, Inc.

250 S. Kraemer Blvd., Brea, California, United States, 92821

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77731

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