Yet another COVID-19 test has been recalled due to a heightened chance of returning false positive results, with almost 200,000 unused Ellume COVID-19 Home Test kits at risk.
The recall comes just a few weeks after Abbott’s Alinity m COVID test and combination COVID, flu and respiratory syncytial virus assay became subject to a false-positive warning of their own, and less than a year after the Ellume test became the first over-the-counter self-test to receive emergency authorization from the FDA.
The Australian company began its voluntary recall of the at-home test kits Oct. 1, citing an undisclosed manufacturing issue that was found to cause a higher rate of false positives than had initially occurred in clinical testing.
Ellume has identified more than 40 lots of the test kits that were affected by the issue. Those lots span about 427,000 individual kits, according to ABC News, approximately 195,000 of which are still unused and are eligible for replacement. The tests were distributed between April and August, with most sold by retailers like Amazon, Target and CVS and a handful of lots distributed by the Department of Defense (DOD).
Anyone who purchased an Ellume test during that time period can complete an online form to determine whether their kit came from the affected lots. If so, they can request a replacement test, regardless of whether they already used it.
Additionally, Ellume will contact anyone who previously tested positive using one of the affected kits. Those who took the test in the last two weeks are encouraged to get retested, while those before them are warned not to assume they’re immune to the virus, since they may not have actually had COVID.
Despite the affected test kits’ increased risk of false positives, Ellume CEO Sean Parsons said in a statement that “the reliability of negative results is unaffected by this issue” and that the company has already implemented new controls to the manufacturing process to address the issue and ensure it doesn’t happen again.
“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,” Parsons said. 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.”
RELATED: Ellume's COVID-19 test nabs first at-home, over-the-counter emergency use authorization
In December, Ellume’s 20-minute antigen test became the first fully at-home assay to receive emergency use authorization from the FDA for over-the-counter sales. In studies, the lateral flow test registered an overall sensitivity of 96% and specificity of 100%.
The FDA’s authorization was followed in February by a $231.8 million deal with the DOD the Department of Health and Human Services to establish a U.S. production facility and churn out 8.5 million of the rapid tests to be distributed across the country.