Ellume, an Australian-based digital diagnostics company, is recalling at least 200,000 COVID-19 rapid at-home test kits following a remarkably high rate of false positives, according to a report on the issue.
Distributors have been instructed to discontinue distribution and quarantine the affected kits immediately, Ellume said.
The Food and Drug Administration also issued an alert this week regarding the tests in the United States.
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The recall will remove the significant number of home-testing kits at a time of especially high demand.
Ellume apologized for the slip-up, and CEO Sean Parsons said the company understands the importance of accurate test results while the pandemic is still taking lives.
“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,” Parsons continued.
Retailers and distributors affected by the recall are being notified, and those who have tested positive while using the kits are directed to take confirmatory tests, Ellume said.
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“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.
