FDA Announces That CDC’s PCR Test FAILED Review, Will Have Emergency Use Authorization REVOKED
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The Innova SARS-CoV-2 Antigen Rapid Qualitative Test, the CDC’s benchmark COVID diagnostic testing system, will be withdrawn for Emergency Use by the end of 2021 due to an inordinate frequency of false positive and negative results.
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 FDA stated on its website.
“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.”
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 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.
In April, the Innova Medical Group sent an Urgent Medical Device Recall letter to all affected device users.