Nearly 200,000 COVID-19 rapid antigen test kits are being recalled over concerns of reporting false positives, according to ABC News.
What are the details?
Australian-based test manufacturer Ellume is recalling the at-home test kits out of concerns over abnormally high rates of false positives.
Ellume was the first FDA-authorized company to sell COVID-19 testing kits to the public in stores. In clinical studies, Ellume tests were 96% accurate, Insider reported.
According to the outlet, roughly 427,000 test kits have been impacted by the issue. 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.
The company said that the affected products will be yanked from store shelves and advised distributors to stop selling those products and immediately quarantine them.
Insider reported that many of these tests were sent to retailers such as Amazon, CVS, and Target for public distributions.
Ellume CEO Sean Parsons acknowledged the recall this week and issued an apology for the stress and confusion any false positives may have caused.
"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 on the recall. "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' statement concluded.
The company vows that it is actively working on the issue that caused the tests to report false positives and is advising all customers to visit the Ellume website to see if their test is included in the recall.
The Food and Drug Administration say that the government agency is "working closely with Ellume to assess the company's additional manufacturing checks and other corrective steps to help ensure that the issue is resolved."