Aussie firm recalls 2m Covid-19 self-test kits sent to US

BRISBANE • An Australian medical technology manufacturer has recalled more than two million at-home Covid-19 test kits shipped to the United States after finding an increased chance of false positives.

The US Food and Drug Administration (FDA) issued an alert on Wednesday that the company, Ellume, had recalled 2.2 million test kits since the issue was detected last month.

A false positive test result indicates that a person has been infected by the coronavirus when they have not. "The FDA has identified this as a Class I recall, the most serious type of recall," the agency said in a notice.

"Use of these tests may cause serious adverse health consequences or death."

The FDA said it had received 35 reports of false positives and no deaths had occurred to date.

Early last month, Ellume announced a voluntary recall of 195,000 test kits after false positive results were reported in some product batches at higher-than-expected rates.

At the time, the company had shipped about 3.5 million test kits to the US.

Ellume said yesterday the recall was expanded after additional lots were found to be affected.

"Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the US," it said in a statement.

"We have, and will continue to work diligently to ensure test accuracy in all cases."

Ellume's rapid at-home coronavirus test kit last year became the first to receive emergency use authorisation in the US.

Among the test kits were those provided to the Department of Defence for distribution to community health programmes.

AGENCE FRANCE-PRESSE