The Food and Drug Administration has announced a recall of more than 2 million Ellume at-home COVID-19 tests due to “higher-than-acceptable false positive test results.”
Ellume first announced a voluntary recall of some of its tests in October for the same issue. The FDA has classified this recall as a Class I recall, the most serious level of recall.
“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,” Ellume founder and CEO Dr. Sean Parsons wrote in a statement. “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,” Parsons wrote, adding that the issue “is limited to specific lots.”
The FDA recommends that consumers should “check if your Ellume COVID-19 Home Test is included in Ellume’s product recall by comparing the lot number on the test carton to the lot numbers on Ellume’s website.”
“Contact your health care provider, urgent care facility, or other COVID-19 testing site and request a COVID-19 molecular diagnostic test if you received a positive test result with one of the affected lots of the Ellume COVID-19 Home Test in the last two weeks and have not already had a follow-up molecular diagnostic test to confirm the positive test result,” the FDA added.
About 35 false positives related to the test were reported to the regulator, but no deaths. The agency said that negative results from those tests are not impacted by the 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 agency wrote.
If you have an unused test from an affected lot, contact the company through its website to request a product replacement.
Demand for at-home COVID-19 tests is still very high, with many consumers reporting that supply can be limited in certain parts of the country. The Biden administration last month announced a $1 billion investment to expand access to at-home COVID-19 tests, which could quadruple the number available by next summer.
“This means companies will be able to expand production of tests even further based on the United States government’s commitment to procure an additional 180 million rapid tests over the course of the next year, with tens of millions more tests coming to market over the course of the next 30 days,” White House coronavirus response coordinator Jeff Zients said at the time.
The U.S. has recently produced an average of around 30 million rapid tests per month; following October’s announcement, there could be around 200 million tests available by December.
