At least 200,000 COVID-19 rapid antigen test kits are now being recalled over concerns that they had been reporting false positives, as noted by ABC News.
The Details
Ellume is an Australian-based test manufacturer and they are now recalling their at-home test kits out of concerns because they kept reporting false positives. Ellume had become the first FDA-authorized company to sell COVID-19 testing kits to the public in the stores. Insider reported that the clinical studies indicated that the Ellume tests were 96% accurate.
The outlet reported that roughly 427,000 test kits have been impacted by this issue. Approximately 195,000 of the kits continue to be unused and subject to recall. Approximately 202,000 have already been utilized. Of this amount, there have nearly been 42,000 positive results, and that’s all well and good. However, it looks like at least a quarter of these positives are inaccurate.
The company definitely made it clear that the affected products were going to be yanked from store shelves and advised distributors to stop selling the products and see to it that they were immediately quarantined.
Insider reported that the great majority of these tests had been sent to retailers such as Amazon, Target, and CVS for public distribution.
Ellume CEO Sean Parsons acknowledged everything about the recall this week, issuing an apology for the stress and confusion that any false positives might 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 his statement regarding 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.”
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 now is vowing that it will actively work on the issue that caused the tests to report these false positives and they are now advising all customers to visit the Ellume website to see if the test is included in the recall. The Food and Drug Administration noted that the agency continues to “work closely with Ellume to assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved.”