Australian medical technology maker Ellume said it has recalled nearly 200,000 self-tests for Covid-19 in the United States due to an increased risk of false positives.
The US Medicines Agency (FDA) warned on Tuesday about the "risk of false positive results with certain lots of Ellume's Covid-19 home test, due to a recently identified manufacturing problem."
The negative results do not appear to be "unaffected by the manufacturing problem," the statement said.
"The FDA is working closely with Ellume to assess the company's additional manufacturing controls and other corrective actions to ensure the issue is resolved."
According to a spokesperson for Ellume contacted on Wednesday, 195,000 of the 3.5 million tests shipped to the United States had been affected, including tests provided to the Department of Defense for community health programs.
"I offer my sincere apologies"
The recall was ordered after reports of false positives at abnormally high rates in certain batches, the company said in a statement dated October 1.
“I sincerely apologize - and apologies from all of our company - for any stress or hardship people may have encountered due to false positive results,” said Ellume founder Sean Parsons.
Ellume's over-the-counter product last year became the first rapid home coronavirus test to receive emergency use authorization in the United States.
The firm said it resumed distribution of tests to U.S. retailers after identifying the cause of the problem and implementing additional controls.
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