The Food and Drug Administration is classifying the recall of the Ellume COVID-19 Home Test for giving false positive results as a Class I recall, the most serious type of recall.
The agency said the “use of these tests may cause serious adverse health consequences or death.” The false positives could delay diagnosis or treatment for another serious non-COVID-19 illness, further spread the virus...
The Food and Drug Administration is warning that certain lots of the Ellume COVID-19 Home Test may be giving false positive results due to a manufacturing issue.
The agency said negative results don’t appear to be affected, and that it’s working with the company to assess its manufacturing checks and take steps to fix the error.
Ellume is asking customers to check if their tests are part of the...
The Biden administration has cut a deal with Australian digital diagnostics company Ellume to increase the availability of its at-home rapid response COVID-19 test kit in the U.S.
The Department of Defense, with the Department of Health and Human Services, will pay $231.8 million for Ellume to deliver 8.5 million tests across the U.S. in accordance with the National Strategy for the COVID-19...
