Bioplex 2200 Anti-ccp System

Summary The Bioplex 2200 Anti-CCP System, a diagnostic test used to detect antibodies associated with rheumatoid arthritis, is being recalled across Canada due to performance issues. The product is classified as a Class I recall, meaning there is a serious potential health risk. This recall affects the test kits distributed throughout Canada.

Product
Bioplex 2200 Anti-CCP System
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2023-03-09
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/68ef5bbd-68a0-43d9-a08b-dd98ddafdac0