Simplexa Covid-19 & Flu A/b Direct
Recall Summary Simplexa Covid-19 & Flu A/B Direct tests are being recalled across Canada due to performance issues with the COVID-19 detection component. This is a Class I recall, the most serious classification, indicating the product could cause serious adverse health consequences or death. The recall affects all units of this diagnostic test distributed in Canada.
- Product
- Simplexa Covid-19 & Flu A/B Direct
- Reason
- Performance - COVID
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2023-02-09
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/76033bb0-cfc2-40ee-bdc7-85dc19b80791