Two Million Ellume Covid Tests Recalled on False Positive Risk

Ellume Ltd. is recalling 2.2 million at-home Covid-19 tests because they risk returning false positives, the U.S. Food and Drug Administration said. The regulator classified the action on Wednesday as a class I recall, the most serious kind, saying it has received 35 reports of false positives from the test made by the Australian company. Incorrect results could lead a person to wrongly receive Covid-19 treatments or isolate when they don’t need to, the FDA said. “The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false positive result,” a company spokesperson said in an email. “We have and will continue to work diligently to ensure test accuracy, in all cases.”