HEALTH

Rapid at-home COVID tests subject to massive recall

UPDATED: OCTOBER 6, 2021 AT 5:14 PM

Photo: Darren England/EPA via Shutterstock, FILE

BY BECKY BRUCE
News Director

An Australian company issued a recall of nearly 200,000 at-home rapid COVID-19 tests, over concerns some of the kits may result in false positives.

The recall would affect around 5.6% of the total number of tests sent to the United States by Ellume, according to the New York Times.

Rapid COVID test recall driven by false positives

CEO Dr. Sean Parsons thinks some 427,000 test kits may have been affected by quality variations in a raw material used in the kit. But about half of that number has already been used. Of those, 42,000 yielded positive results, and Parsons told ABC News around a quarter of those results could be inaccurate. However, he could not provide an exact number of inaccurate tests.

In a statement posted online, Ellume apologized and said it is working to remove the remaining affected tests from store shelves.

“Importantly, the reliability of negative results is unaffected by this issue and are not included within this recall,” the company said. “We offer our sincere apologies for the stress or difficulties people may have experienced due to a false positive result. We have and will continue to work diligently to ensure test accuracy, in all cases.”

The Food & Drug Administration provided more details about the COVID-19 rapid at-home test recall on its website.

How To Prevent the Spread of COVID-19 Coronavirus

COVID-19 coronavirus spreads person to person, similar to the common cold and the flu. So, to prevent it from spreading:

Wash hands frequently and thoroughly, with soap and water, for at least 20 seconds.
Don’t touch your face.
Wear a mask to protect yourself and others per CDC recommendations.
Keep children and those with compromised immune systems away from someone who is coughing or sneezing (in this instance, at least six feet).
If there is an outbreak near you, practice social distancing (stay at home, instead of going to the movies, sports events, or other activities).
Obtain a flu shot.
Seek out the COVID-19 vaccine.