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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