COVID-19 test kit maker Ellume is recalling some at-home tests after learning that they were reporting a higher-than-expected rate of false positive results indicating someone has the virus when they do not.
The Australian company has said the tests were shipped to U.S. retailers and other distributors from April through August. It published a list on its website of the lot numbers on test packages affected by the recall.
The company said about 427,000 tests are in the lots identified in the recall, and nearly 200,000 are unused. Ellume said tests from those lots may provide false positive results at a rate higher than researchers saw during clinical testing.
Ellume said it will email customers who used one of those test kits and received a positive result in the last two weeks. It recommended that people who have not scheduled another test to confirm the result should immediately do so.
The U.S. Food and Drug Administration said Tuesday in a separate statement that people who got a positive result from one of the tests should contact a care provider or urgent care location and ask for a molecular diagnostic test.
The problem was tied to a manufacturing issue, and it does not appear to affect negative results from the tests.
Ellume said about 42,000 affected tests have been used and produced positive results, both accurate and false. That represents about 1% of the 3.5 million tests the company has shipped to the U.S.
MORE ON THE PANDEMIC:
— J&J seeks US clearance for COVID-19 vaccine booster doses
— Washington woman dies after rare blood clot complication
— AstraZeneca asks FDA to authorize COVID-19 antibody treatment
— Vaccines are here. School’s open. Some parents still agonize about virus
See all of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic
HERE’S WHAT ELSE IS HAPPENING:
COLUMBIA, S.C. — South Carolina districts can continue to require face coverings in the state’s schools under an appellate court’s decision.
On Tuesday, the 4th U.S. Circuit Court of Appeals denied state Attorney General Alan Wilson’s request that South Carolina’s law prohibiting school mask mandates be allowed to take effect while a lawsuit over the measure goes forward.
Last month, a federal judge suspended the state from enforcing its rule banning school districts from requiring masks for students. Wilson and Gov. Henry McMaster, both Republicans, had appealed that temporary restraining order, asking the 4th Circuit to restore the ban to avoid changing mask policies across the state now that students are back at school.
The back-and-forth stems from a lawsuit filed by parents of disabled children, represented by the American Civil Liberties Union, arguing that South Carolina’s ban discriminated against medically vulnerable students by keeping them out of public schools as the COVID-19 pandemic continues.
According to state health data, about 75,000 students, teachers and school staff have been infected with COVID-19 this school year, and nearly 200,000 have had to quarantine because of close exposure.
PHOENIX — The coronavirus pandemic is a cause for concern for families who face various policies at schools and day care centers.
The spread of the more infectious delta variant, particularly among people who refuse vaccinations, has caused an increase in infections in children. The coronavirus exposures and illnesses at schools and day cares can mean children get sent home, forcing parents to scramble for childcare.
There’s evidence that masks in schools help reduce virus spread, and most Americans support requiring masks for students and teachers. District policies on masks, testing and quarantines vary widely. Soon after schools reopened in August, the rate of coronavirus infections forced dozens of districts to back off in-person learning.
More than 5.5 million children in the U.S. have tested positive for the coronavirus, with 20% of all child cases coming since this school year began, according to the American Academy of Pediatrics. Kids are at lower risk of severe illness or death, but at least 498 have died.
Vaccines have been available for children as young as 12 since May, but vaccination rates trail adults. Federal data show about half of 16- and 17-year-olds are vaccinated, while 43% of 12- to 15-year-olds are vaccinated; two-thirds of adults are vaccinated.
SEATTLE — Washington state health authorities say a woman in her late 30s has died from a rare blood-clotting syndrome after receiving the Johnson & Johnson coronavirus vaccine.
Public Health Seattle & King County said Tuesday the woman was the fourth person in the United States to die from possible blood clotting issues following the J&J vaccine.
Three deaths were reported before federal authorities temporarily halted J&J vaccinations in April. A spokesperson for the Centers for Disease Control and Prevention says the agency is aware of, and is looking into, additional reported clot deaths since then, including the one in Washington state.
The King County woman received her shot on Aug. 26. She died on Sept. 7. Blood clots are a very rare complication associated with J&J’s vaccine. According to King County authorities, 12.5 million doses of the J&J vaccine had been administered by July 8, 2021, with 38 people having confirmed cases of the unusual type of blood clot. The majority recovered from the issue.
OKLAHOMA CITY — A report from the U.S. Department of Health and Human Services says coronavirus vaccinations have helped reduce infections by 7,500 and deaths by 1,100 among Oklahomans age 65 and older.
The study of Medicare recipients released Tuesday found each 10% increase in vaccination rates resulted in an 11-12% decline in weekly COVID-19 hospitalizations and deaths among Medicare beneficiaries.
Last week, 91% of Oklahomans 65 or older had received at least one vaccination and 80% were fully vaccinated, according to the Oklahoma State Department of Health.
OMAHA, Neb. — The number of new coronavirus cases and hospitalizations in the Nebraska appear to be leveling out. Data from the Centers for Disease Control and Prevention show the state reported 4,775 new cases for the week that ended Friday. That was just above the 4,676 cases reported the previous week but significantly below the roughly 5,300 cases per week the state tallied during the three previous weeks.
The number of virus hospitalizations averaged 415 daily in the past week, which was down slightly from 421 the previous week.
Nebraska has registered a total of 2,840 deaths, according to the CDC.
BATON ROUGE, La. — About 150 people were exposed to the coronavirus at a recent wedding, and those not vaccinated should quarantine, the Louisiana Department of Health said Tuesday.
The department said it has confirmed an outbreak among several people attending the wedding. It says those without symptoms and those fully vaccinated who attended the wedding in Abbeville on Sept. 25 should be tested for the virus.
Unvaccinated people should watch for symptoms while in quarantine, the department said. Those include fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congested or runny nose, nausea or vomiting and diarrhea.
The department says exposed unvaccinated people who test negative during the quarantine period still need to stay in quarantine through Saturday, 14 days after the wedding.
WASHINGTON — The Biden administration on Tuesday ordered Arizona Gov. Doug Ducey to stop using the state’s federal pandemic funding on a pair of new education grants that can only be directed to schools without mask mandates.
In a letter to Ducey, the Treasury Department says the grant programs are “not a permissible use” of the funding. The Treasury Department says the conditions “undermine evidence-based efforts to stop the spread of COVID-19.”
Ducey, a Republican, created the grant programs in August. He launched a $163 million grant program using federal funding he controls, but he made it available only to schools without mask mandates.
Education advocates have filed a lawsuit over Arizona’s mask ban and several other state laws that restrict the power of local governments and school districts to impose COVID-19 requirements.
Those policies conflict with guidance from the CDC, which recommends universal mask wearing for students and teachers in the classroom. Deputy Treasury Secretary Wally Adeyemo asked Arizona officials to explain how it will remedy the problem within 30 days.
GENEVA — The World Health Organization says it’s still reviewing data about Russia’s Sputnik V vaccine as part of hopes that it can be approved for emergency use against the coronavirus, but no decision is imminent.
The clarification comes after Russia’s Health Minister Mikhail Murashko in recent days said administrative issues were the main holdup in the WHO decision-making process about whether to give an emergency use listing to Sputnik V — as it has for about a half-dozen other COVID-19 vaccines.
WHO spokeswoman Daniela Bagozzi said Tuesday only the WHO’s technical advisory group on emergency use listings — not the WHO director-general — has final say about whether a vaccine obtains emergency approval.
Such approval would be a show of international confidence in the Russian vaccine after a rigorous review process. It could pave the way for its inclusion into the COVAX program organized by WHO and key partners shipping COVID-19 vaccines to scores of countries around the world based on need.
The vaccines WHO has approved are Pfizer-BioNTech, AstraZeneca, Johnson & Johnson, Moderna, Sinovac and Sinopharm.
DALLAS — Southwest Airlines has become the latest U.S. airline to require its employees to be vaccinated against COVID-19.
The Dallas-based company said its workers must be fully vaccinated by Dec. 8 to continue working at the airline. Employees can seek exemptions due to medical or religious reasons.
Southwest says it will mandate vaccines because of new rules from the Biden administration that companies with federal contracts must have a vaccinated staff. Southwest’s work for the government includes flying the military in emergencies and carrying mail for the U.S. Postal Service. Southwest has 54,000 employees.
LISBON, Portugal — Portugal will start administering booster shots of the Pfizer COVID-19 vaccine to people ages 65 and older starting next week.
That’s according to the Assistant Secretary of State and Health, António Sales.
The move follows a recommendation by the European Union’s drug regulator to use booster shots in adults, a decision the European Medicine Agency says it based on evidence that antibody levels rise in people aged 18 or older once they are given an extra dose at least six months after their last one.
The World Health Organization’s chief had urged wealthy nations not to use booster doses this year in a widespread way, calling for vaccines available in developing countries first. But some of the 27 EU member nations had already begun administering booster shots.
With 85% of Portugal’s 10 million residents fully vaccinated, it is leading the world’s vaccination charts.
NEW YORK — New York state’s largest health care provider has announced 1,400 employees have been terminated for refusing to be vaccinated against COVID-19.
Northwell Health officials says the terminations represent less than 2% of its total workforce. They say they regret losing any employees and their goal was to comply with the New York state mandate to get people vaccinated.
A statewide vaccination mandate for all hospital and nursing home workers took effect on Sept. 27. It will be expanded to include home care, hospice and adult care facility workers on Thursday.
MOSCOW — Coronavirus deaths in Russia have hit a record for the third time this month, and cases have exceeded 25,000 a day as vaccination rates in the country remain low.
Russia’s state coronavirus task force reported 25,110 cases on Tuesday and 895 deaths.
Officials have blamed low vaccine uptake. Only 33% of Russia’s population of 146 million have received at least one shot of a coronavirus vaccine and just 27% have been fully vaccinated.
Russia’s vast, yet severely underfunded health care system has started to show signs of being overwhelmed by the outbreak. Russian media have reported long lines of ambulances once again forming in front of hospitals in St. Petersburg, the nation’s second-largest city. The Kremlin has said it’s not considering a nationwide lockdown or any other nationwide measures despite the surge.
Some Russian regions have limited attendance of mass events and restricted access to some public places, such as theaters, cinemas, restaurants and bars, to those who are vaccinated, recently recovered from COVID-19 or recently tested negative. Critics argue these measures aren’t enough to slow the surge.
NEW YORK — A COVID-19 vaccine requirement for teachers and other staff members has taken effect in New York City’s million-plus-student public school system.
Mayor Bill de Blasio says 95% of the city’s roughly 148,000 public school staffers had received at least one vaccine dose as of Monday. The nation’s largest school system is one of the first in the country to require inoculations for all its staffers. A similar mandate is set to go into effect in Los Angeles on Oct. 15.
Some 43,000 doses have been administered since the mandate was announced Aug. 23, de Blasio says.
Vaccination rates rose in every school job category after the mandate was announced. District Council 37 of the American Federation of State, County and Municipal Employees, which represents some 20,000 city Department of Education employees, says 93% of those workers had provided proof of at least one COVID-19 vaccine dose as of Sunday, up from 68% at the start of September.
Roxanne Rizzi, who teaches at an elementary school in Queens, waited until Friday to get her first shot. The 55-year-old had resisted the vaccine because she contracted the coronavirus in November and believed natural immunity would protect her. She says she got the shot “for the finances of my family.”
The CDC says people should get vaccinated even if they have already been infected by the virus. The agency says COVID-19 vaccines offer better protection than natural immunity and help prevent getting infected again.
BUCHAREST, Romania — Romania hit a record of more than 15,000 daily coronavirus cases as the country’s intensive care units reach capacity.
Last month, Romania had 1,000 daily cases. But it registered 15,037 new infections Tuesday, almost 3,000 cases more than its previous high.
The surge prompted authorities Monday to suspend non-emergency medical treatments for 30 days to try to ease pressure on hospitals. Raed Arafat, the head of Romania’s Department for Emergency Situation, says, “We do not yet see a trend of capping or falling.”
Romania is the second-least vaccinated nation in the European Union, with only 33% of adults fully vaccinated. It has registered more than 37,000 confirmed deaths since the start of the pandemic.
COPENHAGEN, Denmark — The Norwegian government recommended elderly over the age 85 and nursing home residents should get a third shot six months after having received the second dose of the coronavirus vaccine.
Health Minister Bent Hoeie says the Pfizer vaccine should be given, and those ages 75 to 84 and 65 to 74 should be next in line.
The announcement came after the Scandinavian country had said it would offer people with severe weakened immune systems a third dose of the vaccine. That group includes patients with immune deficiency diseases, organ transplants and cancer patients.
WASHINGTON — Johnson & Johnson has asked U.S. regulators to allow booster shots of its COVID-19 vaccine as the U.S. government moves toward shoring up protection in more vaccinated Americans.
J&J says it filed data with the Food and Drug Administration on giving a booster dose between two to six months after vaccination. The U.S. government last month authorized booster doses of Pfizer’s vaccine in vulnerable groups.
A panel of FDA advisers meets next week to consider boosters for both J&J and Moderna vaccines. It’s part of a sweeping effort by the Biden administration to boost protection amid the delta variant and potential waning of vaccine strength.
The FDA is convening its outside panel of advisers next week to review booster data from both J&J and Moderna. It’s the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention. If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month.
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