COVID-19 coronavirus home test units produced by Australian firm Ellume Photograph:( AFP )
So far, 35 false positives from these tests have been reported to the FDA
The US Food and Drug Administration (FDA) has asked Australian-based biotech company, Ellume, to recall its 2 million at-home COVID-19 test kits, saying that the products were found to be defective and may result in “false positives”.
The company first informed the federal regulatory agency 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.
The defective test kits were manufactured by Ellume between February 24, 2021 and Aug. 11, 2021. So far, 35 false positives from these tests have been reported to the FDA.
Incorrect results could lead a person to wrongly receive COVID-19 treatments or isolate when they don’t need to and might even lead to people avoid vaccination, the FDA said.
The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older.
In a statement posted on the company’s website, founder and CEO Sean Parsons apologised to those who had received a false positive.
“We understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and to take back a bit of control of their lives during this pandemic,” Parsons said.
Ellume says it has corrected the manufacturing problem even as the FDA says they are monitoring the company’s efforts moving forward.
“The FDA is continuing to work with Ellume to assess the company's corrective actions, such as additional manufacturing checks and other corrective steps, to address the reason for the manufacturing issue, and to help ensure that it is resolved and will not recur,” the regulatory agency said in a statement.
(With inputs from agencies)