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Nearly 200,000 at-home COVID-19 test kits are being recalled due to concerns about a high rate of false positives. The Food and Drug Administration announced that a manufacturing issue was identified with over 400,000 Ellume COVID-19 Home Test kits.
"There is an increased chance that tests from the affected lot numbers may give a false-positive result. The voluntary recall is being taken after specific product lots reported false-positive test result rates higher than was observed in clinical testing," Ellume said in a statement.
The company said that of the 427,000 kits it has sold, roughly 202,000 have already been used. Of those tests, there were 42,000 positive results. The company estimates that one-quarter of those positives results could be inaccurate. Ellume said that any negative tests should be considered accurate.
While more than half of the kits have already been used, Ellume pulled the remaining 195,000 rapid tests off store shelves. The FDA said that if you have received a positive test from one of the kits within the last two weeks, you should get a molecular diagnostic test to confirm the result.
The kits were sold at pharmacies across the country, including CVS, Walmart, and Target. They do not require a prescription and promise to provide results within minutes. Some of the tests were also sold to the Department of Defense.
"You have my personal commitment that we have learned from this experience, we have implemented additional controls to ensure our product meets our high-quality standards, and we are going to do everything in our power to regain your trust," Ellume CEO Sean Parsons said in a statement.