Sofia Sars Antigen Fia (2021-04-23)

Sofia SARS Antigen FIA Recall Summary The Sofia SARS Antigen FIA test kit is being recalled across Canada due to a medical device issue. This is a Class I recall, the most serious classification. The recall affects rapid antigen test kits that were distributed nationwide.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-05-13

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b3b10d96-7f02-467b-a217-f9917a6df979