Vitros Immunodiagnostic Products Anti-sars-cov-2 Total Reagent Pack (2020-07-22)

Recall Summary Ortho Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Packs distributed across Canada due to a defect in the medical device used for COVID-19 testing. This is a Class I recall, meaning the product could cause serious harm or death. The recall affects healthcare facilities and laboratories that use this reagent pack for COVID-19 antibody testing.

Reason

COVID - Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-08-28

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/40416a48-e264-41a2-81b9-4a0345b17971