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FDA Announces Voluntary Recall of At-Home COVID-19 Tests

— November 11, 2021

Millions of Ellume at-home COVID-19 tests are being recalled after the FDA determined they are producing an alarming number of false positives.

Earlier this week, a recall was issued for more than two million Ellume at-home COVID-19 tests over concerns they may be producing “higher than acceptable false positives.” The voluntary recalls of the rapid tests were first issued in October, according to the US Food and Drug Administration (FDA). 

COVID-19 graphic
COVID-19 graphic; image courtesy of padrinan via Pixabay,

The FDA has classified this as a Class I recall, which is the most serious type because “use of these tests may cause serious adverse health consequences or death.” The agency said, “false positives could lead to a delayed diagnosis or treatment of the actual cause of a person’s illness; receiving unnecessary Covid-19 treatment which may have side effects; and disregard for precautions against Covid-19, including vaccination.”

So far, there have been 35 reported cases of false positives from people using the recalled tests. According to the notice, the recall includes tests manufactured between February 24 and August 11. They were distributed from April 13 to August 26. When asked about what the agency is doing about the issue, it stated:

“The FDA is continuing to work with Ellume to assess the company’s corrective actions, such as additional manufacturing checks and other corrective steps, to address the reason for the manufacturing issue, and to help ensure that it is resolved and will not recur.”

For now, consumers should avoid using the tests. Anyone who received a positive result while using the affected tests should follow it up with another test as confirmation of a positive result.

Earlier this year, Ellume USA began producing at-home COVID-19 tests after the Biden administration awarded the company $231.8 million to do so. The company is expected the manufacture millions more over the winter months as COVID-19 continues to linger.


More than 2 million Ellume Covid-19 home tests recalled due to false positives

FDA recalls 2.2 million Ellume COVID-19 home tests due to false positives

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