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.”
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CIA whistleblower: analysts given money to bury covid lab-leak theory
The House Select Subcommittee on the Coronavirus Pandemic sent a letter to CIA director William Burns discussing the CIA and a COVID-19 cover-up. The letter asserts that it has knowledge from a whistleblower from the CIA’s “Covid Discovery Team” that was tasked with investigating the origins of the novel coronavirus. “New testimony from a highly credibly whistleblower” alleges that the CIA “rewarded six analysts with significant financial incentives to change their COVID-19 origins conclusion from a lab-leak to zoonosis
Apart from a “lone officer” in the group who believed the virus “originated through zoonosis,” the remaining officials agreed that, on balance of probabilities, the coronavirus was likely the result of a lab-leak.
“According to the whistleblower, at the end of its review, six of the seven members of the Team believed the intelligence and science were sufficient to make a low confidence assessment that Covid-19 originated from a laboratory in Wuhan, China,” the letter reads. “To come to the eventual public determination of uncertainty, the other six members were given a significant monetary incentive to change their position.”
In June, the agency declassified its report that the available evidence on the origins of the coronavirus suggested it “was not genetically engineered.”
New testimony from a highly credible whistleblower alleges @CIA rewarded six analysts with significant financial incentives to change their COVID-19 origins conclusion from a lab-leak to zoonosis. pic.twitter.com/KIemfi2Wgl
— Select Subcommittee on the Coronavirus Pandemic (@COVIDSelect) September 12, 2023
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