Australian Firm Recalls US At-Home Covid Test Kits Over False Positives

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

Australian medical tech manufacturer Ellume said it had recalled almost 200,000 at-home Covid-19 tests in the United States over an increased chance of false positives.

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

The US Food and Drug Administration issued an alert Tuesday over the "potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue".

"Negative results do not appear to be affected by the manufacturing issue," the statement said.