(Patty McMurray) In October, a problem with home COVID test kits produced by Australian company Ellume prompted a recall of 200,000 kits. The in-home covid-19 test was given emergency authorization by the FDA to be used at home by people as young as 2 years old to detect the CCP virus. At the time of the recall Dr. Sean Parsons, the company’s CEO apologized.
Related Gavin Newsom Had Major Adverse Reaction to Moderna Booster Shot: Sources
by Patty McMurray, November 12th, 2021
“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.”
Today, the U.S. Food and Drug Administration (FDA) announced that it’s recalling over 2 million Ellume at-home COVID-19 test kits due to the “false positive” results that are related to a manufacturing defect.
From the FDA website:
Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results
The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue FDA Safety Communication on October 5, 2021.
The FDA has 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.
Curiously, as of 4;15 PM ET today, there is no indication that the in-home test, which can be purchased from a variety of online stores like Target and Amazon on the Ellume.com website, has been recalled. The stores either say the Ellume test is “Sold out” or take the user to a broken page.
The description for the in-home test on the Ellume website reads:
Here’s a screenshot of their response to “frequently asked questions” about “False Positives:
The Ellume website also states that their in-home COVID test is 96% accurate.
The Epoch Times reports – 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.”
The Biden administration had signed a $231 million deal with Ellume, which received approval to produce its tests under the Trump administration last year.
“I can feel my mind getting sharper with Lion’s Mane. I put it in my coffee.”
Organic Lion’s Mane Mushroom, proven to grow new brain cells and synapses. Guard against Alzheimer’s, dementia, and mental decline.
- Regulates blood sugar.
- Reduces high blood pressure.
- Promotes healthy energy levels and combats fatigue.
- Helps to prevent excess blood lipid accumulation.
- Protects heart health.
- Slows biological aging.
- Protects liver health.
- Protects kidney health.
Get your Lion’s Mane from Ascent Nutrition, one of the most pure and potent in the industry.
Save 10% and get free shipping with a subscription!
Stillness in the Storm Editor: Why did we post this?
The news is important to all people because it is where we come to know new things about the world, which leads to the development of more life goals that lead to life wisdom. The news also serves as a social connection tool, as we tend to relate to those who know about and believe the things we do. With the power of an open truth-seeking mind in hand, the individual can grow wise and the collective can prosper.
– Justin
Not sure how to make sense of this? Want to learn how to discern like a pro? Read this essential guide to discernment, analysis of claims, and understanding the truth in a world of deception: 4 Key Steps of Discernment – Advanced Truth-Seeking Tools.
Stillness in the Storm Editor’s note: Did you find a spelling error or grammatical mistake? Send an email to [email protected], with the error and suggested correction, along with the headline and url. Do you think this article needs an update? Or do you just have some feedback? Send us an email at [email protected]. Thank you for reading.
Source:
Support our work! (Avoid Big Tech PayPal and Patreon)DIRECT DONATION
Leave a Reply