Health product recall

Beckman Coulter Au2700/5400 Immunochemistry System - Transferrin Assay

Last updated

Summary

Product
Beckman Coulter Au2700/5400 Immunochemistry System - Transferrin Assay
Issue
Medical devices - Performance issue
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

Beckman Coulter Au2700 Immunochemistry System - Transferrin Assay

2573

OSR6152

Beckman Coulter Au Immunochemistry System - Transferrin Assay

2573

OSR6152

Beckman Coulter Au5400 Immunochemistry System - Transferrin Assay

2573

OSR6152

Issue

It has been determined that transferrin ref OSR6152 lot 2573 does not meet the reagent stability claim stated in the Instructions For Use (IFU). Customers may experience reagent blank shifts, calibration failures, and/or QC failures.

Recall start date: September 4, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Health products - Medical devices - Immunology
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-74301

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