FDA/CDC To Recall PCR Tests and Halt The Emergency Use Authorization

The US Food and Drug Administration (FDA) this week has labelled PCR tests, unfit to diagnose COVID-19 and has ordered an immediate recall to stop using these tests.

“The FDA has identified this as a Class 1 recall, the most serious type of recall. Use of these devices may cause serious injuries or death,” the FDA stated on its website.

So, this begs the question. What were they finding? 

This includes the fact that the test’s performance was not adequately established; That the test had not yet received authorization, and concerns that the data provided by the Innova Medical Group with their emergency use authorization (EUA) application appeared to be copied from data provided by other test manufacturers.

The FDA warns that the Innova SARS-CoV-2 Antigen Rapid Qualitative Test is sold under many names, including:

• Innova COVID-19 Self-Test Kit (3T Configuration)
• Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration)
• Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration)

The FDA recommends that healthcare providers who have used the Innova SARS-CoV-2 Antigen Rapid Qualitative Test-retest any patients who may have experienced an inaccurate result.

This is the second and most recent Class 1 recall for COVID-19 testing. Simultaneously, the FDA provided a letter to the public and healthcare providers, warning them to stop using the affected tests. The test affected by the second recall is the Innova SARS-CoV-2 Antigen Rapid Qualitative Test.

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The FDA goes on to explain the risks associated with false positives and negatives:

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 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.