Posted on 10/06/2021 8:14:34 AM PDT by MNJohnnie
Nearly 200,000 at-home COVID-19 tests in the United States have been recalled by Australian medical tech manufacturer Ellume after the company identified that they produced an incorrect positive result.
Ellume was given an emergency authorization in December by the U.S. Food and Drug Administration (FDA) to supply the COVID-19 Home Test for non-prescription use by symptomatic and asymptomatic individuals aged 2 years and older. The home tests deliver results within 15 minutes.
The Biden administration signed a $231.8 million deal with the company, which initially got the green light from the Trump administration last year, to produce to over 633,000 tests kits per day (19 million per month), of which 8.5 million units were reserved for Americans.
But the FDA on Tuesday said it is “alerting test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue.”
“For these tests, a ‘false positive’ is a test result that indicates that a person has the virus when they do not actually have it. Negative results do not appear to be affected by the manufacturing issue,” the notice reads.
The FDA added that it is working closely with Ellume to “assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved.”
In the meantime, test users are being asked to check if their home tests are included in the recall by comparing the lot number on the test carton to the lot numbers on the company’s website.
Users are also asked to contact their health care provider or urgent care facility to request a COVID-19 molecular diagnostic test if they have received a positive result with the potentially defective at-home test within the last two weeks, and have not yet had a follow-up with a health provider to confirm the positive result.
“You should not assume that you had COVID-19 or have immunity to COVID-19,” the FDA said, while recommending at-home test users still take precautions in line with the Centers for Disease Control and Prevention recommendations.
A spokesman for Ellume told AFP on Wednesday that 195,000 out of 3.5 million tests that were shipped to the United States had been affected.
Some of the recalled tests were provided to the U.S. Department of Defense, according to a report by The New York Times.
The company said in a statement on its website that it had identified the incidence of false positives in specific lots of the tests following a thorough investigation.
“We offer our sincere apologies for the stress or difficulties people may have experienced due to a false positive result. We have and will continue to work diligently to ensure test accuracy, in all cases,” the statement reads.
Ellume is one of several companies who have received emergency use authorization by the FDA for rapid antigen COVID-19 tests and the recall comes amid growing demand for home tests in support of the Biden administration’s efforts to combat COVID-19.
On Monday, the FDA granted emergency use authorization for ACON Laboratories’ Flowflex COVID-19 Home Test, which can be used at home without a prescription.
ACON, a San Diego-based company, plans to produce more than 100 million tests per month, and 200 per month by February 2022, the FDA said in a statement.
We currently have a “pandemic” of false positives. The data being released to make us all agree to get the jabs is mostly made up nonsense based on total crap like these tests. How many gunshot victims were called “Covid hospitalizations” and “Covid deaths” after getting a false positive from a PCR test?
“When are we going to stop this nonsense?”
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Maybe when people wake up and realize China, along with the traitors they put in place in various countries, is behind it.
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Australia: Victoria Premier Daniel Andrews Unveils New Mandarin-speaking, Blue-helmet Wearing Division of Victoria Police to Assist with Lockdowns and Protests
I still can NOT understand why so many people rushed out and stood in horrendous lines to get Tested for a Virus when they weren’t Sick.
You can’t fix Stupid
My girlfriend’s 88 year old grandma passed away about six weeks ago after a massive heart attack and a minor stroke. She lasted about 24 hours in the hospital after it happened.
She was not sick in any way (cold or flu) leading up to it and had not been for a few years, but guess what the official cause of death was on her death certificate...COVID 19.
Follow the money.
I’ve been wondering that since the beginning. Exactly who are all these people they claim to be testing, and why would healthy people go to get tested for a disease of which they have no symptoms?
The main office of our electric company had a big sign on their lawn from October of last year (right before the election) until around April of this year that read FREE COVID TESTING. At a rural electric company.
With things like that going on, none of these statistics are the least bit believable.
My wife's brother had an inoperable cancerous brain tumor. He was on hospice care. He had no symptoms related to Covid that we were aware of. When he died the PCR tests were seemingly available to only celebrities and politicians. His death was labeled “presumptive covid”, and is still counted as one of the approximately 8000 deaths from Covid in our state.
These "Covid death counts", "Covid case counts" and "Covid hospital admittance counts" are pure propaganda.
It has happened all too often and is criminal.
My brother was in last stage of liver failure, his whole body was shutting down. When his vital organs were close to failing the nursing home sent him to the hospital. I was in hourly phone contact with the ICU nurse that whole night. He did not have Covid pneumonia nor did he need a ventilator. He died that night of liver failure and that stopped all his other organs. However his death certificate only lists Covid as cause of death.
A: When the Democrats control The House, Senate and Presidency.
Like magic it will all vanish.
I think there are many false-positives in AZ. Each day, I receive an email saying there were thousands of new cases and XX died of the virus.
Why are the “mistakes” always helpful to exaggerate the threat? Asking for a friend...
He makes the case very clearly that the mRNA vaccines are much more dangerous and unsafe than the actual Covid-19 disease.
This is a very powerful hour long video, well worth your time to view.
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