COVID

Madness

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 Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results

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.

• False-negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause patient harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when presumed negative patients are grouped into cohorts in health care, long-term care, and other facilities based on false test results.
• False-positive results could lead to a delay in the correct diagnosis and the initiation of an appropriate treatment for the actual cause of patient illness, which could be another life-threatening disease that is not SARS-CoV-2. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive patients are grouped into cohorts based on false test results.

Who May Be Affected

• People who were tested using these devices
• Health care providers who may have access to and use these tests or whose patients have used these tests
• Organizers of large testing programs, such as on college campuses, who may be using and distributing these tests for diagnostic use

DYI:  One down and so many more needed to bring a halt to this COVID madness.  Looks to me now that the easy money through testing has now ended these companies will be exiting the false positive game – [along with the revenues earned] – as they disappear into the sunset.  The vast amount of money stolen through this FAKE pandemic is breathtaking.  And now have staggering levels of harms and death from their so called vaccines.  This will only stop when the super majority of Americans simply refuse to comply with any of their insane measures.

Click HERE for the link to the FDA.

DYI