Company recalls at-home COVID-19 test kits

Thousands of Ellume’s at-home coronavirus tests have been recalled after an unexpectedly high volume of false-positive test results. 

The Australian company said in a statement it has “isolated the cause and confirmed that this incidence of false positives is limited to specific lots.” 

Forty-three lots of the company’s tests have been recalled. Those tests were shipped to retailers, the Department of Defense and other distributors between April and August, USA Today reported.

Ellume was the first company that the Food and Drug Administration (FDA) authorized to sell COVID-19 kits at stores like Walmart, Target and CVS as well as on Amazon, according to USA Today. 

The rapid test kits provided results almost immediately and had no prescription requirements. 

In the company’s statement, Ellumes founder and CEO Sean Parsons apologized “for any stress or difficulties” that the inaccurate test results caused.

“You have my personal commitment that we have learned from this experience, we have implemented additional controls, we are continuing to work on resolving the issue that led to this recall and we are going to do everything in our power to regain your trust,” he added. 

Ellume has provided a function for customers to test if their test was defective by entering the number on their test’s carton on their website. Customers will also be alerted if they were affected by a possibly inaccurate test on the test’s app. Ellume will also email customers who received false positive results within two weeks, USA Today said.