The Australian medical technology manufacturer has recalled more than 2 million home tests for COVID-19 sent to the United States after finding an increased likelihood of false positives.
On Wednesday, the FDA said Ellume had withdrawn 2.2 million tests since the problem was discovered last month.
A false positive test result indicates that the person has the coronavirus, but the person does not.
“The FDA has identified this as a Class I recall, the most severe type of recall,” the agency said in a statement. “The use of these tests can cause serious adverse health effects or death.”
The FDA said it has received 35 false positives and no deaths to date.
In early October, Ellume announced a voluntary recall of 195,000 tests after false-positive results were obtained in some batches of products at faster-than-expected rates.
At that time, the company had sent about 3.5 million tests to the United States.
Ellume said Thursday that the recall was expanded after the additional lots affected were found.
“Ellume investigated the problem, identified the root cause, implemented additional controls, and we are already manufacturing and shipping a new product in the US,” the company said in a statement.
“We have and will continue to work diligently to ensure that the tests are accurate in all cases.”
Ellume’s rapid home coronavirus test last year became the first to be approved for emergency use in the United States.
Among the recalled tests were those that were made available to the Department of Defense for distribution to public health programs.