Beckman Coulter Au 2700/5400 Immunochemistry System - Immunoglobulin A (iga)

Recall Summary Beckman Coulter is recalling the Au 2700/5400 Immunochemistry System's Immunoglobulin A (IgA) test across Canada due to performance issues with the system. This is a Class I recall, meaning there is a serious potential health risk. The affected product is used in clinical laboratories for immunoglobulin A testing.

Product
Beckman Coulter Au 2700/5400 Immunochemistry System - Immunoglobulin A (IgA)
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2023-08-03
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/78f5d090-38e5-440a-9323-aab0e45c0c2d