Australian company Ellume recalls 22m COVID tests in US over false positive concerns

Brisbane testing biotech Ellume has recalled 2.2 million of its DIY coronavirus tests in the US, as concerns about false positive results increase.

The US Food and Drug Administration classified the recall action on Wednesday (US time) as a class I recall, the most serious kind, saying it has received 35 reports of false positives from the test made by the Australian company. Incorrect results could lead a person to wrongly receive Covid-19 treatments or isolate when they don’t need to, the FDA said.

Ellume had shipped 3.5 million tests to the US as of October. The recalled tests were distributed between mid-April and late August, the FDA said.

“The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false positive result,” a company spokesperson said in an email. “We have and will continue to work diligently to ensure test accuracy, in all cases.”

The spokesperson said that Ellume has identified the cause of the problem, put new control measures in place and is now making and sending new tests to the U.S.

Ellume had shipped 3.5 million tests to the US as of October. The recalled tests were distributed between mid-April and late August, the FDA said.

A previous recall in October affected about 195,000 unused Ellume tests, the startup said at the time.

At that time Ellume confirmed that it had resolved manufacturing issues with the tests and new stock had been shipped to the location of the recalls.

One of the Biden administration’s earliest moves on Covid-19 testing was a $US232 million investment into expanding Ellume’s manufacturing. The company’s product was the first of its kind to be cleared for use without a prescription by the FDA, in late 2020.

Ellume’s self-administered, single-use test is akin to an over-the-counter pregnancy test. Sold for roughly $US30, it uses a swab to detect proteins known as antigens on the coronavirus’s surface and returns results in 15 minutes.

It was the first over-the-counter test approved for use in the US but is not currently available for use in Australia.

The company has previously told this masthead it is focused on offshore markets, with Australia only recently starting to use rapid DIY self tests.

Earlier Wednesday, the Biden administration announced a $US650 million investment in rapid diagnostic tests for confirming at-home screening results. Earlier this year, the US said it plans to spend $US3 billion to expand the supply of at-home tests.

with Bloomberg

Emma Koehn reports on healthcare companies for The Age and The Sydney Morning Herald. She is based in Melbourne.Connect via Twitter or email.

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