Officials say 2.2 million Ellume tests are now being recalled because of the risk of false positives.
The FDA is making it a class one recall, the most serious type.
The agency has received dozens of reports of false positives, which could lead to a person wrongly receiving COVID-19 treatments.
Here are more of today's COVID-19 headlines:
2nd Queens school closes to in-person education amid outbreak
Another Queens school is temporarily closed by coronavirus transmission in the building, the second this week. Village Academy in Far Rockaway will close today through Nov. 20. Students will return to the school on Nov. 22. The school reported 14 cases among students over the past week and two among staff, according to state data. Nine partial classroom closures at the middle school, which shares a building with other schools. Earlier this week, P.S. 166Q, the Henry Gradstein School, also in Queens went fully remote.
Judge orders Texas to halt school mask mandate ban
A federal judge on Wednesday ordered a halt to the enforcement of Texas' ban on mask mandates in the state's schools. U.S. District Judge Lee Yeakel ruled in Austin that the ban ordered by Republican Gov. Greg Abbott violated a federal law protecting disabled students' access to public education. The nonprofit advocacy group Disabled Rights Texas argued that Abbott's ban prohibited accommodations for disabled children particularly vulnerable to COVID-19. Yeakel prohibited Texas Attorney General Ken Paxton from suing school districts that require students to wear masks as a safety measure. Paxton already had sued 15 school districts to overturn those local mask mandates.
"Governor Abbott's executive order clearly violates federal law, and Attorney General Paxton's enforcement of the order against school districts is now stopped," Kym Davis Johnson, of Disability Rights Texas, said in a statement. "As the court found, Texas is not above federal law, and state officials cannot prevent school districts from providing accommodations to students who are especially vulnerable to the risks of COVID-19."
Austria's chancellor threatens lockdown for unvaccinated people as COVID cases soar
Austria's chancellor on Thursday stepped up threats of lockdown measures for unvaccinated people, as new coronavirus cases in the Alpine nation are soaring. The country's worst-affected province said it plans to take that step next week. Austria has taken a series of measures in recent weeks in an effort to curb the spread of COVID-19 and encourage more people to get vaccinated. On Monday, new rules took effect barring unvaccinated people who haven't recovered from an infection from restaurants, hotels, hairdressing salons and large public events.
Chancellor Alexander Schallenberg said late last month that unvaccinated people in Austria could face new lockdown restrictions if infection numbers continue to rise - which they have. On Thursday, official figures showed 760.6 reported new cases per 100,000 residents over the previous seven days - a rate three times that of neighboring Germany, where record numbers also are causing alarm.
Suffolk County offering free vaccines to kids
The Suffolk County Health Department is administering free COVID-19 vaccines to children ages 5 to 11. Vaccines will be administered at the H. Lee Dennison Building located at 100 Veterans Memorial Highway in Hauppauge on Tuesdays and Thursdays from 4 p.m. to 8 p.m. and on Saturdays from 9 a.m. to 2 p.m. On Thursday, November 11, the vaccine clinic will operate from 9 a.m. to 1 p.m. All children must be accompanied by a parent or legal guardian, who must complete the New York State COVID-19 Vaccine Form for the first dose and attest that they are eligible to be vaccinated.
"I am beyond pleased that the CDC has recommended that children ages 5 to 11 years old be vaccinated against COVID-19," Suffolk County Executive Steve Bellone said. "As a father, I am encouraging all parents who may have questions to talk with their pediatrician or a trusted healthcare provider about the importance of getting their children vaccinated. This vaccine saves lives and it could save the life of your child."
While appointments are not required, they are strongly encouraged. Walk-ins will be available on a first come, first served basis. For more information on the county's vaccine efforts, or to schedule an appointment call 311 or visit SuffolkCountyNY.gov/vaccine.
Mom of 3 who gave birth while battling COVID-19 goes home after nearly 100 days
After spending nearly three months in the hospital on a ventilator battling COVID-19, a South Carolina mom is finally home with her family and newborn baby. It was a moment nearly 100 days in the making when Cierra Chubb walked out of the hospital to rehab. Her healthcare heroes cheered her on after she nearly died from the coronavirus.
MORE CORONAVIRUS COVID-19 COVERAGE
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Centers for Disease Control and Prevention on coronavirus
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