STATEMENT FROM ELLUME CEO DR. SEAN PARSONS REGARDING VOLUNTARY RECALL OF SPECIFIC LOTS OF ELLUME COVID-19 AT-HOME TESTS
In recent weeks, we noted an increased chance that Ellume COVID-19 Home Tests from specific product lots may provide an incorrect positive result. Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots.
In response, 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. More information on this voluntary recall may be found here.
At Ellume, 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. 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.
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.
At Ellume, we remain absolutely committed to developing high-quality digital diagnostics that can be relied on in a health crisis. 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.
Dr Sean Parsons
CEO and Founder
The Ellume COVID-19 Home Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for non-prescription home use. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.