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

Affected products

Affected products

Lot or serial number

Model or catalogue number

DxC 500 AU Clinical Chemistry Analyzer

1.5 or lower

C63520

DxC 500 AU Clinical Chemistry Analyzer

1.5 or lower

C63519

DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module

1.5 or lower

C63521

DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module

1.5 or lower

C63522

DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module

1.5 or lower

C13252

Issue

Beckman Coulter has determined that a modification made by operators to 25 predefined calculated rules, which are included as part of the parameter package, will revert to the default expression following parameter package or software upgrades.

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
Recall date
Identification number
RA-82863

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe