At-home COVID-19 Test Recalled Over False Positives

Some batches of Ellume COVID-19 at-home tests give high numbers of false positives — telling uninfected people they have COVID-19. Hundreds of thousands of the tests are being recalled for being faulty. They were the first test authorized to be sold and are available on Amazon and at CVS, Target, Walmart and other retailers. The tests are easy to use and give results in only 15 minutes. The recalled tests are about 12 percent of what the company has sold in the country.

The problem is in 43 lots that shipped between April and August. You can check their site or call their toll-free number 9-5 Eastern time on weekdays to find out if you have tests that have been recalled. The number is (888) 807-1501. Customers who have the company’s home test app will be contacted. And, people who tested positive from the problem tests will be emailed.  

False positives are a problem on two fronts. A person who thinks they are positive for COVID-19 must self-isolate, whether or not they are ill. So, you can spend unnecessary time away from work and loved ones. They also might believe they are now immune to the virus. People who have gotten false results haven’t gained any immunity to the virus and are as vulnerable as before.

There were 427,00 tests in the lots to begin with. Around 195,000 have yet to be used, and the company will replace them with accurate tests.

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,” said Sean Parsons, the company’s founder and CEO.

He also said, “I offer my sincere apologies — and the apologies of our entire company — for the stress or difficulties people may have experienced due to a false positive result.”

What makes this especially frustrating is that the U.S. lags behind other countries when it comes to rapid, at-home tests for COVID-19. The government has committed money to making them and has some free tests available. But the makers just aren’t keeping up with demand. To have this additional setback that both removes tests from the hands of users and undermines people’s trust is distressing.

Rapid tests here in the U.S. cost at least $14. In Germany, they are less than $5; in the UK, they are free. They are easy to find anywhere you go in those countries. Good luck finding them in our stores! While Ellume was the first test approved by the FDA, we now have eight. Europe has more than 30. People in Switzerland get free rapid tests sent to their homes to test their children daily before school. Here, you’re struggling to find one when you believe you’re ill!

It’s essential to check the website or call to see if a test in your home is part of the recalled lot. A test at home can be an amazing tool to help you know if you are infected. But that’s only true if it is accurate and trustworthy!

Banner image: Ellume

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