As a result of a manufacturing issue resulting in false positives, Brisbane-based biotech firm Ellume has recalled some of its COVID 19 rapid at-home tests from the US market.
The company inked a $231.8 million contract with the US Government to ramp up at-home COVID-19 test production at the beginning of the year and in March it established its first US manufacturing facility in Frederick, Maryland.
The US Food and Drug Administration (FDA) has issued a safety communication stating that the manufacturing issue is limited to “false positives” and that it does not affect “negative results”.
In an official announcement, the company confirmed it is voluntarily recalling specific lots of the Ellume COVID-19 Home Test.
“At Ellume, 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. 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,” said Dr Sean Parsons, CEO and Founder of Ellume in a separate statement.
According to Dr Parsons, the company has already implemented additional controls to ensure the test meets the highest quality standards.