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Thousands of Ellume’s home coronavirus tests have been recalled after a surprisingly high volume of false positive test results.
The Australian company said in a statement that it “isolated the cause and confirmed that this incidence of false positives is limited to specific batches.”
Forty-three batches of the company’s tests have been recalled. These tests were shipped to retailers, the Department of Defense and other distributors between April and August, USA Today reported.
Ellume was the first company authorized by the Food and Drug Administration (FDA) 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 statement, Ellumes founder and CEO Sean Parsons apologized “for any stress or difficulty” caused by the inaccurate test results.
“You have my personal commitment that we have drawn from this experience, we have put in place additional controls, we continue to work on the resolution of the problem which led to this recall and we will do everything to regain your confidence”, he added.
Ellume provided a feature for customers to test if their test was faulty by entering the number on their test carton on their website. Customers will also be alerted if they have been affected by a possibly inaccurate test on the test app. Ellume will also send an email to customers who received false positive results within two weeks, USA Today said.
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