Two million Covid-19 tests recalled in US on false positive risk
WASHINGTON (BLOOMBERG) – Australian company Ellume is recalling 2.2 million at-home Covid-19 tests because they risk returning false positives, the US Food and Drug Administration (FDA) said.
The regulator classified the action on Wednesday (Nov 10) as a class I recall, the most serious kind, saying it has received 35 reports of false positives from the test made by the firm.
Incorrect results could lead people to wrongly receive Covid-19 treatments or isolate themselves when they do not need to, 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 spokesman said in an e-mail. “We have and will continue to work diligently to ensure test accuracy in all cases.”
The spokesman 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 United States.
Ellume had shipped 3.5 million tests to the US as at 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 start-up said at the time.
One of the Joe Biden administration’s earliest moves on Covid-19 testing was a US$232 million (S$314 million) investment into expanding Ellume’s manufacturing.
The company’s product was in late 2020 the first of its kind to be cleared for use without a prescription by the FDA.
Ellume’s self-administered, single-use test is akin to an over-the-counter pregnancy test. Sold for roughly US$30, it uses a swab to detect proteins known as antigens on the coronavirus’ surface and returns results in 15 minutes.
On Wednesday, the Biden administration announced a US$650 million investment in rapid diagnostic tests for confirming at-home screening results.
Earlier this fall, the US said it plans to spend US$3 billion to expand the supply of at-home tests.
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