(Reuters) – Australian diagnostic test maker Ellume said it has recalled certain lots of a COVID-19 home test as they may show false positive results due to a recently identified manufacturing issue.
The U.S. Food and Drug Administration said https://www.fda.gov/medical-devices/safety-communications/potential-false-positive-results-certain-lots-ellume-covid-19-home-tests-due-manufacturing-issue-fda on Tuesday that it was working with the company to assess its additional manufacturing checks and take corrective steps.
The false positive results from the company’s test indicates that a person has the virus when they do not actually have it.
In an announcement dated Oct. 1, Ellume had said that it is investigating the issue and had identified the root cause. The reliability of negative results remains unaffected by the issue and are not included within this recall, it added. The company was not immediately available for comment.
According to a report by New York Times, nearly 200,000 test kits have been recalled by the company, which represents about 5.7% of the about 3.5 million test kits Ellume has shipped to the United States.
The report, citing an interview with Ellume’s Chief Executive Officer Sean Parsons, said that about 427,000 test kits, including some provided to the U.S. Department of Defense, were affected. Roughly half of these have already been used, yielding about 42,000 positive results, Parsons told NYT.
Ellume’s at-home antigen test received Emergency Use Authorization by the U.S. health regulator in December 2020.
(Reporting by Bhanvi Satija in Bengaluru; Editing by Shailesh Kuber)
