Ellume is recalling its COVID-19 Home Test for detecting SARS-CoV-2 infection due to its potential to produce false-positive results, according to the U.S. Food and Drug Administration (FDA).
The move comes in response to a safety communication the FDA released October 5. The recall is categorized as class I, the most serious type, the FDA said. Total affected tests are approximately 2 million.
The FDA issued emergency use authorization for the test in December 2020. It is working with Ellume to determine what corrective actions the company should take.