Almost 200,000 at-home rapid Covid-19 antigen tests are being recalled over abnormally high false positives. Ellume is an Australian-based manufacturer for these rapid tests. They were the first FDA approved tests to be sold in retail stores. The kits are sold on Amazon, CVS, Target, Walmart, and Everlywell Insider reports that the Ellume tests were 96% accurate in clinical trials.
According to Ellume, “Tests from 43 lots sent to retailers and distributors between April and August were included in the recall.” About 427,000 kits in total were recalled.
The Blaze reports, “Approximately 195,000 of those kits are still unused and subject to recall, and approximately 202,000 have already been used. Of those, there have been nearly 42,000 positive results, of which as many as a quarter of those positives may have been inaccurate.”
Ellume confirmed the products would be removed from store shelves and has instructed retailers to quarantine the kits.
Ellume CEO, Sean Parsons, issued a statement saying, “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….” 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.”
Ellume suggests any customers visit their website to see if they have recalled kits.
The FDA states, “[We] are working closely with Ellume to assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved.”
With supply chain issues plaguing the U.S, CVS had to limit their sale of the kits when the Delta virus surged. According to Insider, “The purchasing restraint is caused by manufacturing delays from suppliers of the tests. The limited tests include the Abbott BinaxNOW and Ellume at-home tests.”
Before the tests were recalled, CVS limited in-store purchases to 4 kits at a time.
Ellume reports the cause of the inaccurate results is from an issue in variation with one of the test kit’s components. They are working to “implement additional controls and are continuing to work on resolving the issue that led to this recall.”