Australian diagnostic test maker Ellume has recalled some batches of its COVID-19 home test amid concerns the swab kits falsely informed healthy patients they had the coronavirus.
The Brisbane company said of the 427,000 tests that were affected, it had recalled about 195,000 tests as they were unused.
“In recent weeks, we noted an increased chance that Ellume COVID-19 Home Tests from specific lots may provide an incorrect positive result,” the company said in a statement.
“Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots.
“We worked with the Food and Drug Administration (FDA) to voluntarily remove affected Ellume tests from the market.”
Ellume added: “Importantly, the reliability of negative results is unaffected by this issue and are not included within this recall.
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.
“We offer our sincere apologies for the stress or difficulties people may have experienced due to a false positive result. We have and will continue to work diligently to ensure test accuracy, in all cases,” the company said in its recall notice.