The U.S. Food and Drug Administration classified the recall of Ellume’s over-the-counter COVID-19 home test as Class 1, the most serious type of recall, after the Australian diagnostic test maker removed some of its tests from the market last month.
Ellume had cited higher-than-acceptable false positive test results for SARS-CoV-2 as the reason for the recall.
A “false positive” indicates that a person has the virus when they actually do not.
The antigen test, which detects proteins from the SARS-CoV-2 virus from a nasal sample, is available without a prescription for use by people above 2 years of age with or without COVID-19 symptoms.
The agency said on Wednesday there have been 35 complaints of the antigen test giving false positive results, but no death had been reported related to the test.
Ellume has so far recalled 2,212,335 tests in the United States.
