COVID-19: Ellume’s at-home test recalled by FDA
The U.S. Meals and Drug Administration categorized the recall of Ellume’s over-the-counter COVID-19 dwelling take a look at as Class 1, essentially the most critical sort of recall, after the Australian diagnostic take a look at maker eliminated a few of its assessments from the market final month.
Ellume had cited higher-than-acceptable false constructive take a look at outcomes for SARS-CoV-2 as the explanation for the recall.
A ‘false constructive’ signifies that an individual has the virus once they really don’t.
The antigen take a look at, which detects proteins from the SARS-CoV-2 virus from a nasal pattern, is obtainable and not using a prescription to be used by individuals above two years of age with or with out COVID-19 signs.
The company mentioned on Wednesday there have been 35 complaints of the antigen take a look at giving false constructive outcomes, however no dying had been reported associated to the take a look at.
Ellume has up to now recalled 2,212,335 assessments in america.
(Reporting by Mrinalika Roy in Bengaluru; Enhancing by Shinjini Ganguli)