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 was behind the issue because he didn’t want to divulge how the test works.
Ellume’s test looks for viral proteins shed by COVID-19, which is different from the gold-standard approach of tests that look for the genetic material of the virus.
The kit includes a nasal swab, a chemical solution and a testing strip.
The nose sample is collected with a special adapter that can shortened when being used on young children.
Next, a few drops of the solution are added to the sample, which is placed in a small device that connects via Bluetooth to a smart phone app.
The app then displays the results and helps interpret them. Users can also connect with a health professional via the app.
The test comes with a nasal swab analyzer that connects to an app on users’ smartphone, and gives results in 15 minutes
The FDA says false positives could lead to a person delaying diagnosis or treatment for the actual cause of illness or receiving unnecessary treatment
Last year, in a clinical study, the test demonstrated 96 percent overall accuracy, correctly identifying 95 percent of positive cases and 97 percent of negative cases.
In December 2020, it was the first completely at-home test kit to receive emergency use authorizations from the U.S. Food and Drug Administration (FDA).
The FDA said that the false positives could lead to a person delaying diagnosis or treatment for the actual cause of his or her person’s illness or receiving unnecessary treatment.
Additionally, the person could think because he or she is positive that they have immunity and don’t need to get vaccinated.
In a statement posted to the company’s website on Thursday, Parsons apologized for the recall.
‘At Ellume, we understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and to take back a bit of control of their lives during this pandemic,’ he wrote.
‘To those individuals, I offer my sincere apologies – and the apologies of our entire company – for any stress or difficulties they may have experienced because of a false positive result. ‘