Ellume is recalling certain lots of its COVID-19 Home Test due to unacceptably high false-positive results, the U.S. Food and Drug Administration announced recently.
The FDA labeled this a class 1 recall on Wednesday, the most serious type of recall indicating use of the tests can cause serious harm or death. Approximately 35 false-positives have been reported thus far, with no fatalities.
More than 2.2 million tests are affected by the news on top of the 200,000 recalled last month for the same issue. Australia-based Ellume was the first company to gain FDA authorization for an over-the-counter COVID test back in February.
The administration maintained negative results are not affected. However, it advises those who tested positive within the last two weeks to reach out to their doctor.
Sean Parsons, founder and CEO of Ellume, released a statement on 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,” Parsons said. “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."
Read more about the recall here.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.