Almost 200,000 at-home COVID-19 tests are being recalled due to an unusually high number of false positives, ABC News reported. The issue has affected about 427,000 tests made by Ellume, a medical diagnostics company, including some provided to the Defense Department. The roughly 195,000 tests recalled have not been purchased by customers. The false positives are triggered by a defective component in the test’s ingredients, though it has no effect on the validity of negative tests.
“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,” Ellume CEO Sean Parsons said in a statement. “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.”