Ellume has recalled more than 2.2 million COVID-19 Home Test kits due to a high rate of false positives.
The recalled tests were manufactured between April 13 and August 26 and sold throughout the U.S.
The rapid at-home antigen tests use nasal swabs to check for proteins from the SARS-CoV-2 virus, which causes COVID-19.
The FDA said no deaths were reported, but false positives could lead to a person receiving unnecessary COVID-19 treatment, or a delayed diagnosis and treatment of an actual illness.
The recall is an expansion of an earlier recall Ellume issued in October for 200,000 at-home test kits due to the same issue. According to the recall, around 35 false positives were reported with the test.
Anyone who may have received a positive test from the recalled kits should contact their health care provider, urgent care facility, or other COVID-19 testing site and ask for a COVID-19 molecular diagnostic test to confirm the positive test result.