Ellume is recalling nearly 200,000 rapid at-home COVID-19 antigen tests out of concerns over an abnormally high rate of false positives observed from certain lots of its tests.
Roughly 427,000 test kits, including thousands sent to retailers and some provided to the Department of Defense, have been impacted by the issue.
About 195,000 of these kits are still unused and subject to the recall. About 202,000 have already been used, the company said. Of those, there have been around 42,000 positive results, of which as many as a quarter of those positives could have been inaccurate. However, the company said it's difficult to determine an exact ratio.
Ellume is removing the affected product from store shelves and said distributors should cease distribution and quarantine those products immediately.
This recall yanks hundreds of thousands of rapid COVID-19 tests off the shelves at a time when demand for these tests has already skyrocketed. Amid shortages, many of the major retail pharmacy stores announced they are limiting purchases to contend with supply constraints.
Meanwhile, Ellume is notifying consumers, retailers and distributors affected by the recall. It's warning those consumers who have tested positive to take confirmatory tests, as their initial Ellume results may have been incorrect.
Ellume CEO Sean Parsons apologized for the incident, acknowledging how much rides on accurate test results during this pandemic.
"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 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 said in the statement.
Ellume said it has identified the root cause as an issue in variation with one of its test kit's components, and said it has "implemented additional controls" and are "continuing to work on resolving the issue that led to this recall."
While the recall was triggered by false positives, the company said the reliability of negative results from its kits is unaffected by this issue: approximately 160,000 tests from affected lots produced negative results.