Taqpath Covid-19 Rt-pcr Kit & Applied Biosystems Covid-19 Interpretive Software (2020-10-09)

Recall Summary The TaqPath COVID-19 RT-PCR Kit and Applied Biosystems COVID-19 Interpretive Software are being recalled across Canada because of issues with how the COVID-19 test results are interpreted by the software. This is a Class I recall, meaning there is a serious potential health risk. The recall affects all users of these testing devices and software in Canada.

Reason

COVID - Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-10-23

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/9b075162-740a-4469-beb5-54614c486833