“This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States,” the FDA said, adding that it “is concerned about the risk of false results when using this test.”
Up to more than 209,000 of these tests were recalled by SML Distribution LLC after they were distributed in the U.S. in January and February, the FDA said. The agency emphasized this is a “Class I recall, the most serious type.”
SML Distribution has not given “adequate data to show the test works correctly,” according to the FDA.
The company acknowledged in a recall statement that a false test result “can lead to unnecessary quarantine and testing resources” if it leads a person to believe they are COVID-19 positive when they are not sick.
The recalled test involves a nasal swab to detect the virus, according to the FDA.
If you or someone you know was recently tested with this unauthorized test, the agency suggests raising concerns with a health care provider.
Health workers who have tested patients using the test within the past two weeks should “consider retesting your patients,” the FDA advises.
5:51 p.m.: Lease signs still hang from many storefront windows, but some commercial landlords are seeing growing demand for retail space as COVID-19 subsides.
While the harshest public health restrictions lifted months ago, many businesses have been hesitant to open or expand brick-and-mortar locations after suffering bruising revenue losses during lockdowns and facing high inflation.
But recent financial reports from Canada’s largest commercial real estate owners suggest that retailers and employers are starting to make the move back to in-person work.
5:32 p.m.: A Canadian soldier who publicly spoke out against federal vaccine requirements while in uniform has been charged, while another Armed Forces member has been fined after posting a video supporting the Freedom Convoy.
The Defense Department confirmed the charges against Warrant Officer James Top and finding of guilt against Aviator Riley MacPherson on Wednesday, adding six other service members remain under investigation for criticizing government policy.
A 22-year veteran of the Canadian Armed Forces who served in Afghanistan, Top faces two counts of conduct to the prejudice of good order and discipline for comments that he made while wearing his uniform in February.
A copy of the charge sheet provided by his lawyer, Phillip Miller, says one of the charges relates specifically to a video posted to TikTok in which the army reservist criticized vaccine requirements for military personnel and other federal employees.
The second charge deals with similar criticisms that Top made in Surrey, B.C., around the same time, also while in uniform. A professional-looking video of those comments was later published to social media.
Canadian Armed Forces members are severely restricted in the comments they can make while in uniform, particularly when it comes to criticizing government policies, in large part to protect the military from any perception of politicization.
5:16 p.m.: China’s tightening Covid rules and extended lockdowns are making a 2020-style V-shaped economic recovery a dim possibility this time around.
The slump in output may not be as deep as two years ago, when most of the country was under some form of restriction from late January through much of February following the outbreak in Wuhan. Currently, areas making up only about 30 per cent of gross domestic product are under full or partial lockdown, according to estimates from Holdings Inc.
However, this time around, given the ability of the highly infectious Omicron variant to evade stringent controls, there’s greater risk of cities shutting down and then reopening repeatedly over several months. Major hub Shanghai is still in lockdown after five weeks, and while cases are easing there now, Beijing and other cities are tightening restrictions to curb their own outbreaks.
The result is that businesses will have to live with the ever-present threat of disruption of the kind that’s halted production at companies like Tesla Inc. and roiled supplies at Sony Group Corp. Consumer confidence and spending will likely also remain weak, putting the government’s GDP growth target of about 5.5 per cent for this year further out of reach.
“The main concern is that given the high transmissibility of Omicron, the containment and lockdowns could be in place longer than in 2020,” said Wei Yao, head of research for Asia Pacific and chief economist at Societe Generale SA. “The confidence shock could be more sizable because the difficulties of extinguishing outbreaks make it almost impossible for business and households to forecast an end to recurring disruptions.”
4:27 p.m.: Quebec’s unpreparedness and its delayed reaction to the COVID-19 pandemic led to the province losing almost $1 billion in its procurement of personal protective equipment, the auditor general said Wednesday.
The government waited too long and then rushed into purchasing items such as masks and gloves at high prices, Guylaine Leclerc said in her report released Wednesday.
By the end of March 2021, the value of the equipment purchased by the province had dropped by $938 million, she said. Of that amount, the province lost $671 million in the value of its stockpile and another $267 million connected to contracts for equipment and prepaid orders.
“The Health Department didn’t plan any measures to create a sufficient supply of personal protective equipment in the event of a pandemic, such as making prior agreements with suppliers or creating a stockpile,” Leclerc wrote.
“It was therefore forced to urgently purchase equipment to protect the population while prices skyrocketed.”
Quebec spent $1.4 billion on procedural masks and N95 masks alone, she said.
Leclerc told reporters on Wednesday the government should have acted faster to procure equipment, noting that the first bulk purchases were made on March 22, 2020, despite the fact the first infection in the province was detected on Feb. 27 of that year.
3:49 p.m.: California is approaching another summer amid growing anxiety over COVID-19 as outbreaks increase and officials try to determine when this new wave will crest.
Although case rates are climbing, experts note they are doing so at a more modest pace than the first Omicron surge, which began spiking in December. California’s numbers of COVID-19 hospitalizations are also lower than some states on the East Coast.
But with Memorial Day, graduations, proms and other seasonal events on the horizon, officials are concerned about the upward trend worsening.
“We are seeing more activity, and so it is time to break out your mask and break out your tests and just be a bit more cautious than maybe you were a month ago,” said Dr. Sara Cody, public health director and health officer for Santa Clara County. “Even if you got omicron during the omicron surge, you can still get COVID again, unfortunately.”
California is reporting about 8,000 daily coronavirus cases in the last week, up 18 per cent over the previous week’s tally of 6,800 cases a day. The statewide test positivity rate has climbed to 4 per cent; a week ago it was 3 per cent.
Coronavirus-positive hospitalizations also have started to tick upward, but the number of patients needing intensive care has remained relatively stable, hovering near record lows for the pandemic.
3:46 p.m.: The world finds itself awash in COVID-19 vaccines, but governments can’t get them into arms fast enough, as hesitancy and logistical hurdles threaten to indefinitely extend the pandemic.
Shots that were once rare are now piling up and even expiring, a problem on the agenda of a second global COVID-19 summit the U.S. is co-hosting Thursday. President Joe Biden kicked off the first summit eight months ago by announcing the U.S. would donate another 500 million doses to the international vaccination campaign, nearly doubling its total pledge.
But now, vaccine makers are idling production or face shutdowns as demand for shots wanes, even with the world still far from a target of inoculating 70% of humanity. Republicans in Congress have so far blocked additional funding for the U.S. and international vaccination campaigns.
Advocates for widespread inoculation say participants at the virtual summit need to come up with a plan to shift focus from producing vaccines to administering shots. They warn that failure raises the risk of new variants arising, potentially with the ability to evade vaccine immunity and spark yet another wave of infections and deaths.
“We need to invest now because we’re going to continue to see more transmissible variants,” said Thomas Bollyky, director of the global health program at the Council on Foreign Relations. “We are rolling the dice, in a game that we keep losing, to bet that we’re not going to end up with a variant that upends the progress we’ve seen.”
3:35 p.m.: U.S. COVID-19 cases are up, leading a smattering of school districts, particularly in the Northeast, to bring back mask mandates and recommendations for the first time since the omicron winter surge ended and as the country approaches 1 million deaths in the pandemic.
The return of masking in schools is not nearly as widespread as earlier in the pandemic, particularly as the public’s worries over the virus have ebbed. But districts in Maine, New Jersey and Pennsylvania have brought masks back, with a few in Massachusetts also recommending them even as the school year enters its final weeks.
Maine’s largest school district, in Portland, said this week masks would return, with Superintendent Xavier Botana saying that was the “safest course at this time” amid rising cases. Bangor, Maine, schools also brought back a universal mask requirement.
High schools in the suburbs of Pittsburgh and in Montclair, New Jersey, a commuter suburb of New York City, also announced a return to masking, albeit temporarily through this week. According to data from the Centers for Disease Control and Prevention, most of the counties in the country considered to have “high” levels of COVID-19 are in the Northeast.
In parts of Massachusetts that have seen high levels of COVID-19 transmission, authorities are also recommending masks in schools.
Reactions have ranged from supportive to angry. On the Facebook page of Woodland Hills High School in suburban Pittsburgh, one woman called the change “#insane.”
2:15 p.m. A COVID-19 outbreak in Cleveland’s clubhouse, including a positive test for manager Terry Franconia, led Major League Baseball to postpone Wednesday’s series finale between the Guardians and White Sox to allow for more testing and contact tracing.
It was the first coronavirus-related postponement in the league so far this season, which started on April 7.
MLB released a statement saying only there were “multiple positive COVID-19 tests” within Cleveland’s organization.
Franconia, who has dealt with serious health problems the past two seasons, tested positive a few hours before the scheduled first pitch. The team said the 63-year-old Franconia currently is not showing any symptoms.
Guardians bench coach DeMarco Hale, who filled in when Franconia stepped away last season, was expected to manage the series finale. However, he also tested positive along with “multiple coaches and other team support staff members,” according to Guardians spokesman Bart Swain.
The Guardians are off on Thursday before opening a three-game series in Minnesota on Friday. It’s unclear at this point who will manage the team, and it’s likely the Guardians will bring up several minor league coaches and field coordinators for the series.
Cleveland’s team recently had a coronavirus outbreak, with infielders Owen Miller, You Chang and pitchers Cal Quantile and Anthony Castro all being placed on the COVID-19 injury list.
Franconia has been in a good health this season following two challenging years. In 2020, he managed just 14 games during the pandemic-shortened season before he was hospitalized with gastrointestinal issue.
Last year, Franconia struggled after undergoing off season surgery on his foot and left the team in July.
Franconia is in his 10th season with Cleveland. He won two World Series titles with the Boston Red Sox.
You must be logged in to post a comment.