More than 200,000 of Ellume tests from affected lots have already been used.
Ellume is recalling nearly 200,000 rapid at-home COVID-19 antigen tests out of concerns over an abnormally high rate of false positives observed from certain lots of its tests.
Roughly 427,000 test kits, including thousands sent to retailers and some provided to the Department of Defense, have been impacted by the issue.
About 195,000 of these kits are still unused and subject to the recall. About 202,000 have already been used, the company said. Of those, there have been around 42,000 positive results, of which as many as a quarter of those positives could have been inaccurate. However, the company said it's difficult to determine an exact ratio.
Ellume is removing the affected product from store shelves and said distributors should cease distribution and quarantine those products immediately.
Editor’s Note: This story is being updated.
July 27, 2022 – President Joe Biden has tested negative for COVID-19 after testing positive a week ago.
Biden, who has been in isolation for the past 5 days, has no fever and his symptoms are “steadily improving.” according to to his personal physician, Kevin O’Connor, DO. The president will resume his normal duties and end his isolation.
The president,…
As new COVID-19 variant Omicron spreads like wildfire across the world, two top Democrats – Sens. Elizabeth Warren (D-MA) and Cory Booker (D-NJ) – have announced they’ve contracted the virus.
“I regularly test for COVID & while I tested negative earlier this week, today I tested positive with a breakthrough case,” Warren tweeted. She said she is feeling only mild symptoms and is “grateful for the protection provided against serious illness that comes from being vaccinated & boosted.”
Warren added, “As cases increase across the country, I urge everyone who has not already done so to get the vaccine and the booster as soon as possible – together, we can save lives.”
Booker tweeted that he had mild symptoms Saturday and tested positive as well.
“I’m beyond grateful to have received two doses of vaccine and, more recently, a booster — I’m certain that without them I would be doing much worse,” he said.
Democratic Senators Elizabeth Warren and Cory Booker both tested positive for COVID, and both were vaccinated and boosted. Both Warren and Booker ran for President in 2020.
Chief White House medical adviser says breakthrough infections are inevitable as cases surge
Richard Luscombe at The Guardian:
The Omicron variant of Covid-19 has “extraordinary spreading capabilities”, the top US infectious diseases expert said on Sunday, and promises to bring a bleak winter as it continues “raging through the world”.
Dr Anthony Fauci’s warning came ahead of the busy holiday travel period, which he said would elevate the risk of infection even in vaccinated people.
In an interview with NBC’s Meet the Press, Fauci, Joe Biden’s chief medical adviser and head of the National Institute of Allergy and Infectious Diseases, urged Americans to get booster shots and wear masks.
He also appeared to attempt damage control over Vice-President Kamala Harris’s contention that the Biden administration “didn’t see” the Omicron or Delta variants coming.
[...]
Fauci looked ahead to a scheduled national address by Biden on Tuesday, in which he said the president would “upscale” elements of the White House Covid winter plan.
“He’s going to stress several things,” Fauci said. “… Getting people boosted who are vaccinated, getting children vaccinated, making testing more available, having surge teams out, because we know we’re going to need them because there will be an increased demand on hospitalisation.”
The White House reset comes at the end of a week in which the US surpassed 800,000 deaths from coronavirus and saw a 17% surge in cases and a 9% rise in deaths.
Medical experts have warned of an Omicron-fueled “viral blizzard” sweeping the country. Biden has spoken of a “winter of severe illness and death” among the unvaccinated.
Fauci repeated such dire predictions on CNN’s State of the Union.
“One thing that’s clear is [Omicron’s] extraordinary capability of spreading, its transmissibility capability,” he said. “It is just raging through the world.
“This virus is extraordinary. It has a doubling time of anywhere from two to three days in certain regions of the country, which means it’s going to take over. If you look at what it’s done in South Africa, what it’s doing in the UK, and what it’s starting to do right now, the president is correct.
“It is going to be tough. We can’t walk away from that because with the Omicron that we’re dealing with it is going to be a tough few weeks to months as we get deeper into the winter. We are going to see significant stress in some regions of the country, on the hospital system, particularly in those areas where you have a low level of vaccination.”
Many cases of Omicron are so-called “breakthrough” infections. Florida, one of the hardest-hit states throughout the pandemic, reported on Sunday that about 30% of new infections were in people vaccinated but yet to receive a booster.
Fauci and other experts have said immunisations alone will not prevent the spread of Omicron, but are confident that the risk of serious disease or death is vastly reduced in those who are vaccinated.
Dr Francis Collins, director of the National Institutes of Health, told CBS’s Face the Nation he was concerned about the effects of Omicron on those who are not vaccinated.
“It’s a brand new version and so different that it has the properties to potentially be evasive of the vaccines and other measures that we’ve taken,” he said.
“The big message for today is if you’ve had vaccines and a booster you’re very well protected against Omicron causing you severe disease. Anybody who’s in that 60% of Americans who are eligible for a booster but haven’t yet gotten one, this is the week to do it. Do not wait.”
Drs. Anthony Fauci and Francis Collins both went on the Sunday morning shows today to give dire warnings about the state of Omicron that are "raging through the world."
