Australian diagnostic test maker Ellume has recalled some batches of its COVID-19 home test, saying they may show false-positive results due to a recently identified manufacturing issue.
The company said of the 427,000 tests that were affected, it had recalled about 195,000 tests as they were unused.
"Ellume has investigated the issue, identified the root cause and implemented additional controls," the company told Reuters on Wednesday.
Ellume, whose at-home antigen test received Emergency Use Authorisation by the US health regulator in December 2020, has so far shipped 3.5 million tests to the United States.
The US Food and Drug Administration said on Tuesday that it was working with the company to assess its additional manufacturing checks and take corrective steps.
The company said it had restarted manufacturing of its updated test kits and would soon resume their distribution.
Details about the recall were first reported by the New York Times.
Australian Associated Press