Connect with us

COVID-19

FDA Announces Recall Of Over 2 Million Home COVID Tests Over False Positives

The FDA’s recall is a Class I, meaning it is “the most serious” of the types of recalls.

Published

on

Ellume COVID-19 Home Test
Ellume COVID-19 Home Test

The U.S. Food and Drug Administration has announced a recall of over 2 million at-home COVID-19 tests from the Australian medical technology company Ellume due to potential false positives.

The FDA’s recall is a Class I, meaning it is “the most serious” of the types of recalls. The FDA warned that “Use of these tests may cause serious adverse health consequences or death.”

“The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older. The Ellume COVID-19 Home Test is available without a prescription for use by people with or without COVID-19 symptoms,” the FDA explained, adding, “The FDA issued an Emergency Use Authorization (EUA) on December 15, 2020 and authorized a revision to the EUA on February 11, 2021 to allow emergency use of the Ellume COVID-19 Home Test.”

“The company first informed the FDA about the defect in some lots in October,” NPR reported. “On Wednesday, the FDA said it had identified additional lots that have been affected by the manufacturing defect. The defective tests were manufactured by Ellume between Feb. 24, 2021 and Aug. 11, 2021. So far, 35 false positives from these tests have been reported to the FDA.”

As reported by CNN, “In February, the Biden administration announced a $231.8 million award for Ellume USA for production of its at-home tests for the US. But demand for home tests has remained high and supply limited. This fall, the Biden administration announced billions more dollars to help make more tests available.”
A spokesperson for Ellume told
The New York Times that the cause of the defects has now been identified.

“Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,” the spokesperson said. “Importantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue.”

You may like

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published.

COVID-19

Fauci’s NIH gives another $3.5 million to EcoHealth despite dangerous past of coronavirus research

Published

on

Screen Shot 2021 05 17 at 10.47.34 AM

Just before he retires, Dr. Anthony Fauci has pushed through a new five-year grant for EcoHealth.  EcoHealth Alliance, is the U.S. nonprofit that Fauci and the National Institute of Health’s funds, “to conduct dangerous coronavirus research in partnership with China’s Wuhan Institute of Virology prior to the global Covid-19 pandemic” reports National Review.

Over the next five years, the troublesome EcoHealth will receive over $3.25 million; their first check comes this year for $653,392. The grant is one of four concurrent NIH grants that EcoHealth has; three of the grants were awarded after the start of the Covid-19 pandemic.

The description of the grant on the NIH RePORTER website is to analyze “the potential for future bat coronavirus emergence in Myanmar, Laos, and Vietnam.”

“This is high-risk research that involves going into remote, often inaccessible areas, and sampling bats and bat excreta, and then returning those samples to laboratories in population centers where they attempt to isolate the virus … and then seek to characterize the threat level posed by the virus,” said Richard Ebright, a biosafety expert and professor of chemistry and chemical biology at Rutgers University. “This is one of the kinds of research that may have been directly responsible for the current pandemic.”

The term gain-of-function research has become very controversial since the global Covid-19 pandemic, and National Review reports on the subject:

This newest EcoHealth project wouldn’t qualify as gain-of-function research, Ebright said. Gain-of-function research involves extracting viruses from animals and engineering them in a lab to make them more transmissible or dangerous to humans. But Ebright said two of EcoHealth’s grants do involve gain-of-function research and enhanced potential pandemic research on coronaviruses. And even if the current description of the new project doesn’t involve gain-of-function research, that doesn’t mean it couldn’t later.

From securing funding to completing the research, it is a six-year process, Ebright said, and the project is bound to change over those six years. “If researchers robotically followed what they proposed six years ago, they would not be taking into account developments in their own labs and in the field at any point along the way,” he said. “You have to have this flexibility. That also means you need oversight to make sure the flexibility isn’t going into forbidden areas.”

Going into forbidden areas is exactly how EcoHealth and its president, Peter Daszak, previously got into trouble. Starting in 2014, the U.S. government temporarily paused funding for gain-of-function research due to concerns over biosafety and biosecurity. When some of EcoHealth’s research – involving infecting genetically-engineered mice with hybrid viruses – seemed to cross that line, NIAID staff and EcoHealth leaders crafted work-around guidelines to allow the nonprofit to continue its work.

You may like

Continue Reading
Advertisement

Trending Now

Advertisement

Trending

Proudly Made In America | © 2022 M3 Media Management, LLC