Posted on 11/13/2021 9:00:13 PM PST by SeekAndFind
The U.S. Food and Drug Administration (FDA) confirmed Thursday it is recalling some 2 million Ellume at-home COVID-19 testing because they can produce “false positives” due to a manufacturing defect.
The firm first informed the federal regulatory agency about the defect in some lots in October. But on Wednesday, the FDA said it identified additional lots that were affected by the manufacturing defect, made between Feb. 24, 2021, and Aug. 11, 2021.
To date, about 35 false positives from the COVID-19 tests were reported to the FDA. No deaths have been reported related to the test, according to the agency.
A “false positive” indicates that an individual has contracted the CCP (Chinese Communist Party) virus, which causes COVID-19, when they actually do not.
The FDA noted that false positives could lead to “delayed diagnosis or treatment for the actual cause of the person’s illness, which could be another life-threatening disease that is not COVID-19” or receiving “unnecessary COVID-19 treatment from a health care provider,” which may “result in side effects.”
Another problem, the FDA noted, is isolation, including monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work.”
Underscoring the severity of the issue, the FDA said it “identified this as a Class I recall, the most serious type of recall … use of these tests may cause serious adverse health consequences or death.”
The antigen test detects proteins from the CCP virus from a nasal sample, and it’s available without a prescription for use by people aged 2 years and older. It also comes with an analyzer that connects with a smartphone app to show users to perform the test and understand the test results.
Ellume has recalled 2,212,335 tests in the United States to date. Earlier this year, the Australia-based firm announced it had about 200,000 of its tests.
The Biden administration had signed a $231 million deal with Ellume, which received approval to produce its tests under the Trump administration last year.
In October, Dr. Sean Parsons, Ellume’s chief executive, announced that the firm had created more safeguards to stop the problem from occurring again.
“I’m very sorry that this has happened,” he told the New York Times at the time.
“We’re all about chasing accuracy, and to have these false positives is disappointing.”
And a spokesperson said that the “root cause” of the issue was identified. The company is already shipping new products inside the United States, the spokesperson added to the NY Times.
The Epoch Times has contacted Ellume for comment.
I wonder how many false positives we’ve seen since the start of COVID-19 testing.
Hmm
They were so happy to use tests they knew they were using incorrectly and generating massive amounts of false positives from before, to get the covid hysteria boiling over
This is surprising... that they admitted it.
Can anyone get this to Aaron Rodgers and Ben Rothlisberger?
Wrong dare…too bad.
They have been using a false positive test on everyone since this whole scam started.
How about the 5 billion NOT at home covid tests that gave / still give mostly false positives?? They going to recall / stop using them??
I don’t think any medical provider is going to rely on a patient’s home test. They will do their own to confirm. So no false positives in the counts from home tests.
A few months ago the CDC quietly announced that the notoriously bad PCR test was being deprecated, and that instead a test should be used that could accurately distinguish between Covid and regular flu/colds.
The announcement was posted in FR at the time.
This was not a mistake. Eptein was not positive.
Why would anyone do this at home when there are tons of places doing free testing.
That’s why I’m skeptical. When people use at-home tests they avoid the government’s tentacles. Without at-home tests people will have to involve the government. This may be the first attempt to keep citizens from withholding their private, health results.
I agree. Here is the reason I think they want to get rid of the at home test. I believe if the mandate of “shot or test” ever happened, they want to make the test as uncomfortable as possible so people will give up and take the shot. Taking a test at home would be convenient and easy to manipulate. TPTB can’t have that!
So they're not on some database that will be used for God knows what.
I bought several home test kits for about $25 each. My kids were at their mom's house and a young cousin came over. The next day the cousin tested positive for Covid. So my kids thought they had been exposed. Fortunately I had provided them with test kits. They used it 3 days after the exposer and again at 6 days. Both were negative.
So I bought more. Money well spent.
You’re exposed to covid and all kinds of bugs every time you leave the house. Stop being a paranoid germaphobe freak.
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