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The United States Food and Drug Administration (FDA) has classified a voluntary recall of 2 million COVID-19 home tests manufactured by Brisbane-based Ellume that were delivering ‘false positive’ results as a ‘Class 1 recall’ - the most serious type of recall it can issue.
“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 FDA said.
The recall comes after the FDA issued an alert earlier this week, notifying test users, caregivers and health care personnel about the potential for false positive results with certain lots of the Ellume-manufactured test, resulting from a manufacturing issue.
The manufacturing problem meant some people were receiving false positive results - indicating that a person has COVID-19 when they do not actually have it. Negative results were not affected by the manufacturing issue.
In a statement on the Ellume website, the company says it has isolated the cause and confirmed this incidence of false positives is limited to specific lots.
“We worked with the Food and Drug Administration (FDA) to voluntarily remove affected Ellume tests from the market. Importantly, the reliability of negative results is unaffected by this issue and are not included within this recall,” Ellume said.
“At Ellume, we remain committed to developing high-quality digital diagnostics that empower our users to manage their health. Patient well-being and product quality are our first priorities throughout every step of the manufacturing and supply chain process. We understand you are counting on us to do nothing less.
“We offer our sincere apologies for the stress or difficulties people may have experienced due to a false positive result. We have and will continue to work diligently to ensure test accuracy, in all cases.”
The news comes 11 months after the FDA issued an Emergency Use Authorisation to permit the use of the Ellume COVID-19 test in the US.
Test users have been told to compare the lot number on the test carton to the lot numbers on Ellume’s website.
Ellume CEO Dr Sean Parsons has also issued a statement and an apology, noting that the recall 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”.
“To those individuals, I offer my sincere apologies – and the apologies of our entire company – for any stress or difficulties they may have experienced because of a false positive result,” Dr Parsons said.
“You have my personal commitment that we have learned from this experience, we have implemented additional controls to ensure our product meets our high quality standards and we are going to do everything in our power to regain your trust.”
Updated at 9.20am AEDT on 11 November 2021.
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