Simplexa Covid-19 Direct Assay

Simplexa COVID-19 Direct Assay Recall The Simplexa COVID-19 Direct Assay, a COVID-19 test product, is being recalled across Canada due to a manufacturing defect. This is a Class I recall, the most serious classification. The defect affects all units distributed in Canada.

Product
Simplexa Covid-19 Direct Assay
Reason
Manufacturing defect
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2022-01-10
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/3ab64990-d942-4943-aa00-d7942be904c6