The U.S. Food and Drug Administration (FDA) is recalling more than two million COVID-19 rapid tests made by Australian company Ellume.
The test was believed to be a game changer because it comes with a nasal swab analyzer that connects to an app on users' smartphones and can provide results within 15 minutes.
But in an announcement issued on Wednesday, the federal agency said a manufacturing issue was causing tests to return false positives, meaning people are told they have COVID-19 when they actually do not.
At least 35 false positives have been reported to the FDA to date.
It comes a little over a month after Ellume announced it was voluntarily recalling 200,000 kits due to the same defect.
The FDA said on Tuesday that it is recalling 2.2 million at-home COVID-19 rapid test kits from Australian manufacturer Ellume (above)
So far, there have been 35 reports made to the FDA of the teats returning false positives. Pictured: FDA headquarters in White Oak, Maryland
Ellume first informed the FDA of the manufacturing defect in October, during which time the FDA issued an alert.
However, after more reports of false positives, the FDA identified the issue as a Class I recall, which is the most serious type of recall.
'Use of these tests may cause serious adverse health consequences or death,' the FDA wrote in its notice.
The 2.2 million recalled tests were manufactured between February 24, 2021 and August 11, 2021.
This means that the recalled tests makes up 62 percent of the 3.5 million kits Ellume has sent to the U.S.
Ellume CEO Dr Sean Parsons told The New York Times in October that the problem s being caused by one the kits' raw materials.
He did not reveal which ingredient
