427,000 at-home COVID-19 tests recalled due to higher-than-expected false positive rate

RALEIGH, N.C. -- Here's the latest news and information on COVID-19 and the COVID-19 vaccines.

4:59 p.m.
Wake County Public Health has confirmed an outbreak of COVID-19 at Brookdale Wake Forest, an assisted living and memory care facility at 611 Brook St. in Wake Forest.

This is the facility's third outbreak. The previous outbreaks occurred in January and May 2020. The N.C. Department of Health and Human Services defines an outbreak as two or more people - residents or employees - testing positive for the virus.

12:45 p.m.
3,598 new COVID-19 cases were reported in North Carolina on Wednesday.

The percent of positive tests in the state is 9.2%.

2,586 people are currently hospitalized with COVID-19.

Hospitalizations have dropped 14 percent since two weeks ago.

There are currently 702 adult ICU COVID-19 patients.

133 more COVID-19 deaths were reported on Wednesday.

9:25 a.m.
More Americans have died from COVID-19 this year than from the virus in all of 2020, according to newly updated data from Johns Hopkins University.

More than 353,000 COVID-19 deaths have been reported since Jan. 1, compared with 352,000 COVID-19 deaths in the first 10 months of the pandemic.

In the last month, the U.S. has reported more than 47,000 deaths.

8:55 a.m.
AstraZeneca, the drugmaker that developed one of the first COVID-19 vaccines, has asked the U.S. Food and Drug Administration to authorize the emergency use of a first-of-a-kind antibody treatment to prevent the disease.

The Anglo-Swedish company said Tuesday that the treatment, known as AZD7442, would be the first long-acting antibody combination to receive an emergency authorization for COVID-19 prevention. If authorized, the drug would likely be limited to people with compromised immune systems who don't get sufficient protection from vaccination.

Click here for full story

8:30 a.m.
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.

WEDNESAY MORNING HEADLINES
Saint Augustine's University in Raleigh resumes in-person classes Wednesday.

That comes after school leaders abruptly moved all classes online last week, citing health and safety concerns. There's still no word as to a specific COVID-19 jump or another health risk that preceded the decision to move classes online.

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 Department of Homeland Security this week issued an intel notice warning that extremists, including white supremacists and other would-be domestic terrorists, are likely to "threaten violence or plot against healthcare personnel, facilities, and public officials in response to renewed and expanding COVID-19 mitigation measures."

The document, distributed Monday to U.S. law enforcement and government agencies and obtained by ABC News, noted that anti-vaccine messaging will likely increase as vaccine mandates spread.



TUESDAY
Q&A: What does it mean that J&J wants FDA to authorize booster shots
EMBED More News Videos

Dr. Alexa Mieses Malchuck answers your questions about the latest news in the COVID-19 pandemic.



8:55 p.m.
During its Tuesday meeting, the Wake County School Board voted to continue its mask and face-covering mandate.

'Consider children of color:' Black parents in Wake County push to keep school mask mandates
2 p.m.
The Dept. of Homeland Security this week issued an intel notice warning that extremists are likely to "threaten violence or plot against healthcare personnel, facilities, and public officials in response to renewed and expanding COVID-19 mitigation measures."

EMBED More News Videos

The Dept of Homeland Security this week issued an intel notice warning that extremists are likely to "threaten violence or plot against healthcare personnel, facilities, and public officials."



The confidential document, distributed Monday to law enforcement and government agencies around the country, noted that anti-vax messaging and conspiracy disinformation is likely to increase as vaccines continue gaining formal government approval and are subsequently mandated for more and more workplaces and entertainment locations. The document was obtained by ABC News.

12:40 p.m.
2,703 new daily COVID-19 cases were reported on Tuesday.

The percent of positive tests in the state is 9.4%.

2,705 people are currently hospitalized in the state with COVID-19.

93 more COVID-19 deaths were reported on Tuesday.

10:15 a.m.
The U.S. Department of Health and Human Services (HHS) announced that a new report shows that COVID-19 vaccinations may have helped prevent roughly 11,000 new COVID-19 infections and 1,600 deaths among seniors in North Carolina during the first five months of 2021.

The study, which was conducted by researchers with HHS's Office of the Assistant Secretary for Planning and Evaluation (ASPE), also found that nationally, vaccinations were linked to a reduction of approximately 265,000 COVID-19 infections, 107,000 hospitalizations, and 39,000 deaths among Medicare beneficiaries between January and May 2021.

8:45 a.m.

New data shows how many people in North Carolina have had COVID-19 multiple times.

From March 2020 through September 20, 2021, a total of 10,812 people in the state had confirmed cases of COVID-19 multiple times (accounting for .8% of all cases). The researchers only counted positive COVID-19 tests at least 90 days prior, in an attempt to avoid multiple positive tests through the same infection.

That 90-day interval is part of the CDC definition of a reinfection case of COVID-19.

NCDHHS said the number of reinfection cases has dramatically increased since the arrival of the Delta variant. The number of reinfection cases per week approximately doubled around July and then tripled around August.

The numbers also show that 94 people died after contracted a reinfected COVID-19 case. That's approximately .6% of the state's total COVID-19 deaths.

To take a look at the data yourself, click here.

7:10 a.m.
Johnson & Johnson asked the Food and Drug Administration on Tuesday to allow extra shots of its COVID-19 vaccine as the U.S. government moves toward expanding its booster campaign to millions more vaccinated Americans.

J&J said it filed a request with the FDA to authorize boosters for people who previously received the company's one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators.

TUESDAY MORNING HEADLINES
Students and staff in Harnett County can attend indoor classes today without wearing a face mask.

The Harnett County School Board voted Monday night to make mask-wearing optional, despite the objections of local health advisors.

In addition, students exposed to a positive COVID-19 case, but have not yet tested positive for the virus, only have to quarantine for 7 days--instead of the previous 10 days that health officials recommend.

According to our newsgathering partners at the News & Observer, the district superintendent Aaron Fleming warned the board that the 4-1 vote could have some unintended consequences. For example, he said some schools may have to turn to remote learning at times if COVID-19 cases and quarantines rise, as they have in other districts across the country that have made face masks optional.
In Wake County, the school board is scheduled to make its mandatory monthly vote on its COVID-19 masking policy.

Parents voiced their opinions over Zoom last night when the board met.

The district will also release the first look at its school reassignment plan for next year. The plan includes base attendance areas for three new schools: Apex Friendship Elementary School, Barton Pond Elementary School and Herbert Akins Road Middle School.

Parents will be allowed to review and comment on the reassignment plan before the board votes on it in November.

And in Durham, Broadway makes a return to DPAC on Tuesday night.

The Band's Visit kicks off a six-day run at the theater. It's the first Broadway show there since the pandemic started back in 2020.

DPAC is requiring proof of vaccination or a recent negative COVID-19 test for all indoor events.
Copyright © 2021 ABC11-WTVD-TV/DT. All Rights Reserved - The Associated Press contributed to this report.