Nov. 10 (Reuters) – 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 manufacturer removed some of its tests from the market last year. 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 he actually does not have it.
The antigen test, which detects proteins of the SARS-CoV-2 virus from a nasal sample, is available without a prescription for use by people over the age of two with or without COVID-19 symptoms.
The agency said on Wednesday that there were 35 complaints about the antigen test giving false positive results, but no deaths had been reported in connection with the test.
Ellume has so far recalled 2,212,335 tests in the United States.
Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli
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