Health product recall

Dxc 500i Clinical Analyzer and Dxc 500 AU Clinical Chemistry Analyzer

Last updated

Summary

Product
Dxc 500i Clinical Analyzer and Dxc 500 AU Clinical Chemistry Analyzer
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalogue number

Dxc 500i Clinical Analyzer

Software V. 1.3.5 or earlier

C63521

Dxc 500i Clinical Analyzer

Software V. 1.3.5 or earlier

C63522

Dxc 500 AU Clinical Chemistry Analyzer

Software V. 1.4.5 or earlier

C63520

Dxc 500 AU Clinical Chemistry Analyzer

Software V. 1.4.5 or earlier

C63519

Issue

Beckman Coulter identified a software issue affecting DxC 500i and DxC 500 AU Analyzers when testing plasma samples. Following user configuration of a chemistry test to nondefault units, subsequent activation of a draft configuration in the system configuration page may revert units to the system default without notifying the user.

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
Industry
Recall class
Type II
Recall date
Identification number
RA-82613

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