Posted on 07/28/2021 6:13:46 PM PDT by Hojczyk
The Food & Drug Administration issued a class I recall for a defective COVID rapid test that had been the “benchmark” for testing in the United States. It continues an alarming trend of problems with COVID tests in the United States.
“The FDA has classified the recall of this test as a Class I recall, the most serious type of recall,” the government agency said. “The FDA also has issued a warning letter to Innova Medical Group, Inc.”
Innova describes itself as “the world’s largest manufacturer of rapid antigen tests and leader in COVID-19 testing solutions globally.” The FDA states the reasons for the COVID test 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.
(Excerpt) Read more at beckernews.com ...
The CDC are totally derelict in their duty to provide a quick and accurate test quickly and cheaply.
Why are they not defunded?
Not to be confused with Inova Healthcare
Recalled because it has “false negatives.”
None have been recalled or stopped from “false positives?”
Owned by a company founded by Charles Huang, PHD educated in Wuhan with a PHD in marketing from Scotland
How bout we just use the term “don’t work and shouldn’t be trusted”
Just when you think this whole COVID debacle can’t get any worse…..
The article suggests false results in both directions.
and the replacements are free... right?
Joe and Tony didn’t get their 10% each.
IBTVPs say Oh, this can’t be true! Not credible!
🙃
Worse was just now reading about federal officers releasing infected, symptomatic illegals into red state towns...
Sirri Americans so gurrible! We Chinese make this virus then make you buy crap that no work!! W.H.O. is our lackey. We make money serring you this stuff no work!! You people die because you so stupid! When you gonna learn?
So the test was giving false positives and false negatives...meaning, the Covid numbers are totally bogus.
Good grief! This whole damn thing is so screwed up.
All you people who have had covid and think you’re immune, you had better get vaccinated quick, because you can’t be sure you had it.
It may have been a false positive.
Signed, your caring government official
bookmark
💰🏨
How bout we just use the term “don’t work and shouldn’t be trusted“
********so if you WERE sick, blow snot in a rag, and you could test Negative, and if you were Not sick, spit into a rag, and get Quarantined because you were Positive.
Great!
The noose is tightening.
The FDA states the reasons for the COVID test 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."
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