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The Australian medical technology company Ellume has recalled over 2 million of its at-home COVID-19 tests over potential false positives.
The recall, defined by the FDA as Class I, is “the most serious” of the types of recalls. “Use of these tests may cause serious adverse health consequences or death,” the FDA notes.
The test, according to the FDA, “detects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older.” It “is available without a prescription for use by people with or without COVID-19 symptoms” and “uses an analyzer that connects with a smartphone app to show users how to perform the test and understand the test results.”
A spokesperson for Ellume told The New York Times the root cause of the problem has been identified.
“Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,” said a spokesperson. “Importantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue.”
As reported by NPR, “The company first informed the FDA about the defect in some lots in October. On Wednesday, the FDA said it had identified additional lots that have been affected by the manufacturing defect.”
Last month, Dr. Sean Parsons, the company’s chief executive, said that the company had created more measures to stop the problem from happening again.
“I’m very sorry that this has happened,” he said. “We’re all about chasing accuracy, and to have these false positives is disappointing.”
The FDA described the reason for the recall, stating:
Ellume is recalling certain lots of the COVID-19 Home Test because they have higher-than-acceptable false positive test results for SARS-CoV-2. The reliability of negative test results is not affected. For these tests, a false positive test result shows that a person has the virus when they do not have it and could lead to:
There have reportedly been 35 cases reported where the devices showed a false positive, but it is unknown how many false positives the defective devices actually demonstrated.
As reported by CNN, “In February, the Biden administration announced a $231.8 million award for Ellume USA for production of its at-home tests for the US. But demand for home tests has remained high and supply limited. This fall, the Biden administration announced billions more dollars to help make more tests available.”