Beckman Coulter Au2700/5400 Immunochemistry System - Transferrin Assay

Recall Summary Beckman Coulter is recalling the Transferrin Assay for use with Au2700/5400 Immunochemistry Systems across Canada due to performance issues with the test. This is a Class I recall, indicating a serious issue. The recall affects laboratories and healthcare facilities using this assay system in Canada.

Product
Beckman Coulter Au2700/5400 Immunochemistry System - Transferrin Assay
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2023-09-18
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/26a90d57-87e2-449a-9ca5-b0b81206f509