President Trump holds the Abbott Labs coronavirus test at the White House on March 30. Photo: Win McNamee/Getty Images

The FDA has received at least 15 reports that suggest Abbott Labs coronavirus tests are inaccurately telling patients that they do not have the virus, FDA said in a Thursday press release citing early data.

Why it matters: These tests have been widely distributed by the federal government in response to the pandemic. The U.S. deployed over 235,000 tests to public health laboratories in every state across the U.S., Assistant Secretary of Health Adm. Brett Giroir said on Monday.

What they're saying: "We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue. We will continue to study the data available and are working with the company to create additional mechanisms for studying the test," Tim Stenzel of the FDA's Center for Devices and Radiological Health said in a statement.

  • "This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test," he said.
  • Specifically, the FDA says that Abbott tests may be incorrectly telling users that they do not have the coronavirus.

What's next: The FDA says it is working with Abbott to review reports of inaccurate test results. Abbott has agreed to conduct further clinical studies on how the tests interact with COVID-19 positive patients, the agency said.

Go deeper: AMA cautions use of coronavirus antibody tests to determine "immunity"

Go deeper

Aug 9, 2020 - Health

Ohio governor urges Americans not to lose faith in testing after false positive

Ohio Gov. Mike DeWine (R) said on CNN's "State of the Union" Sunday that Americans shouldn't think testing for the coronavirus is "not reliable or doesn't work," after he received a false positive result from an antigen test last week.

Why it matters: DeWine is one of six governors who have agreed to pool their resources, along with the Rockefeller Foundation, in order to acquire 3 million antigen tests amid severe delays and the lack of a national testing strategy.

Updated 4 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Annelise Capossela/Axios

  1. Global: Total confirmed cases as of 3 a.m. ET: 20,092,855 — Total deaths: 736,254 Total recoveries — 12,350,879Map.
  2. U.S.: Total confirmed cases as of 3 a.m. ET: 5,094,565 — Total deaths: 163,465 — Total recoveries: 1,670,755 — Total tests: 62,513,174Map.
  3. Politics: Trump claims he would have not called for Obama to resign over 160,000 virus deathsHouse will not hold votes until Sept. 14 unless stimulus deal is reached.
  4. Business: Richer Americans are more comfortable eating out.
  5. Public health: 5 states set single-day coronavirus case records last week — A dual coronavirus and flu threat is set to deliver a winter from hell.
  6. Sports: The cost of kids losing gym class — College football is on the brink.
  7. World: Europe's CDC recommends new restrictions amid "true resurgence in cases."

Why you should be skeptical of Russia's coronavirus vaccine claims

Photo: Alexey Druzhini/Sputnik/AFP via Getty Images

Russian President Vladimir Putin announced Tuesday that his country has registered a coronavirus vaccine and said that one of his daughters has already been inoculated, AP reports.

Why it matters: Scientists around the world are skeptical about Russia's claims. There is no published scientific data to back up Putin's claims that Russia has a viable vaccine — or that it produces any sort of immunity without significant side effects.