CDC Issues Laboratory Alert Over FDA’s Recall on PCR COVID Tests
On July 21st, The CDC issued a Laboratory Alert, urging laboratories and testing sites to abandon the CDC 2019-nCOV RT-PCR Tests and transition to another FDA-authorized alternative to test for COVID-19.
This Laboratory Alert comes in regard to the FDA’s Class I Recall of the SARS-CoV-2 Antigen Rapid Qualitative Test manufactured between September 2020 - March 2021. As defined by the FDA: “Class I is the most serious type of recall. Use of these devices may cause serious injuries or death.”
False Negatives
The tests initially received Emergency Use Authorization (EUA), however as the SARS-CoV-2 virus mutated over time, resulting in genetic variation and many false negatives, rendering these tests ineffective.
False Positives
Aside from false negatives due to mutuations, shockingly—these tests also produced False Positives. As stated in the FDA’s Recall: “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.”
What does this mean?
These were the very same tests Americans were using to diagnose COVID-19 and set their State’s lockdown. This factor corrupts the medical information taken and data collected and used during this time.
Many Americans have lost their businesses, jobs, homes—lost the lives family members and friends—based upon these faulty tests that were issued during Emergency Use Authorization. We based State-to-State guidelines on these tests. Lives have change forever due to the misinformation provided by these tests. With many Americans injecting COVID vaccines that were authorized under Emergency Use Authorization—What will the next Emergency Use Authorization (EUA) to be Recalled by the FDA?
Access to EUA Fact Sheet Documents:
EUA Fact Sheet Summary:
