Rchitect I System - Ebv Vca Igm Calibrator (2020-11-03)

Recall Summary Architect I System EBV VCA IgM Calibrator products distributed across Canada have been recalled due to a medical device issue. The calibrator is used in testing equipment to measure antibody levels for Epstein-Barr virus infections. This is classified as a Class I recall, which is the most serious type.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2020-11-13
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/cd89d15d-fced-4cb9-bc8b-2ba0560654ce