NEW YORK – The US Food and Drug Administration said on Wednesday that Ellume has recalled its COVID-19 Home Test following reports of false positive results with the test.
The FDA — which classified the recall as Class I, issued when the agency believes use of the medical device could lead to serious injuries or deaths — said that there were 35 reports of false positive results with Ellume's test. More than 2.2 million of the tests are being recalled.
The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from patients ages 2 and older. It uses nasal samples and is available without a prescription for symptomatic and asymptomatic individuals, the FDA said. The agency granted Emergency Use Authorization for the test in December 2020, making it the first OTC at-home test to receive such designation.
Last month, the FDA issued an alert warning of the potential for false positive results with certain lots of the test, saying manufacturing issues were the cause of the incorrect results, though negative results aren't affected by the issues.
According to the agency, Ellume, which is based in Australia and has offices in Valencia, California, is advising test users and caregivers to check if their test is from an affected lot, and to contact their healthcare provider, urgent care facility, or COVID-19 test provider to request a COVID-19 molecular test to confirm a positive test result if they used a test from an affected lot within the past two weeks and have not already received a confirmatory positive test result with a molecular test.