Recall on Covid-19 test - FDA: Use of these devices may cause serious injuries or death

Recall on covid-19 test

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.

The test has not been authorized, cleared, or approved by FDA for commercial distribution in the United States.

Recalled Product
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))

Device Description
The Innova SARS-CoV-2 Antigen Rapid Qualitative Test claimed to determine if a person has an active COVID-19 infection. The test used a nasal swab sample and test strip to detect specific proteins, called antigens, from the SARS-CoV-2 virus. If the nasal sample had SARS-CoV-2 antigens, a colored test line should have appeared on the test strip, indicating that the person may have COVID-19. If the nasal sample did not have SARS-CoV-2 antigens, a colored line should not have appeared on the test strip. The test has not been authorized, cleared, or approved by FDA for commercial distribution in the United States.

Reason for Recall
Innova Medical Group is recalling its SARS-CoV-2 Antigen Rapid Qualitative Test. Labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. The performance characteristics of the test have not been adequately established, presenting a risk of false results.

https://www.fda.gov/medical-devices/medical-device-recalls/innova-medical-group-recalls-unauthorized-sars-cov-2-antigen-rapid-qualitative-test-risk-false-test

• Category: Depopulation Agenda,Health Concerns,The Evil Cartel / Pure Evil,Vaccine / Mandatory Agenda
• Duration: 00:59
• Date:  2021-06-27 07:41:20
• Tags:   no-tag