Ellume COVID-19 Home Test Voluntary Recall
In September 2021, we noted an increased chance that Ellume COVID-19 Home Tests from specific 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.
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.
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.
What does this mean for you?
If you purchased an affected Test Kit, you can request a replacement by completing the form below.
We apologize for the complexity of the form but we are required to track and report false positive results to the FDA.
Is your test affected?
We need to check if your product has been affected and is a part of our voluntary recall.
Please select the option that reflects your test status:
Need to talk to someone - 1-888-807-1501 (9 a.m. to 5 p.m. ET, Monday - Friday)