Innova SARS-CoV-2 Antigen Rapid Qualitative Test performance characteristics have not been adequately established, presenting a risk of false results.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Innova SARS-CoV-2 Antigen Rapid Qualitative Test (also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration))
Continue reading on FDA site: Innova Medical Group Recalls SARS-CoV-2 Antigen Rapid Qualitative Test
The Centers for Disease Control and Prevention (CDC) announced this week that its PCR test has failed its full review and will have its Emergency Use Authorization revoked.
The Innova SARS-CoV-2 Antigen Rapid Qualitative Test, the CDC’s benchmark COVID diagnostic testing system, will be withdrawn for Emergency Use by the end of 2021 due to an inordinate frequency of false positive and negative results…