COVID-19 Home Test Being Recalled For Possible False Positive Results

Now that the school year is well underway, stocking up on COVID-19 self-test kits is a must. To help families navigate the ongoing pandemic, at-home COVID test kits are a convenient, beneficial, and reassuring option. But, only when they work.

If you recently bought a home test for COVID-19, you may want to check to see if it’s part of the Ellume recall. In a statement released on October 5th, the U.S. Food and Drug Administration warned that certain lots of the Ellume COVID-19 Home Test may produce false-positive results. 

Potential False Positives With Ellume COVID-19 Antigen Test

Ellume’s website reports that the rapid COVID-19 antigen test at home was voluntarily recalled. Tests from the affected lot numbers are more likely to give false-positive results, according to Ellume. Thus, someone taking the test could receive a “false positive” result indicating they have the COVID-19 virus when they actually do not. In spite of this, FDA reports that negative results don’t appear to be affected by the manufacturing problem.

Ellume’s website indicates that many retailers nationwide sold and distributed the COVID-19 Home Tests. Additionally, the Ellume COVID-19 Home Test Kits affected by the recall were distributed from April 2021 to September 2021.

Check the lot number on the test carton against the lot numbers on Ellume’s website to see if your kit is part of the recall. For individuals who used affected tests and received a positive result, the FDA has additional recommendations.

Recommendations For Ellume Test Users

If you have tested positive with an Ellume COVID-19 Home Test from one of the affected lots in the last two weeks, consult a healthcare provider. The result is not necessarily negative. 

If you received a positive test result with one of the affected lots of the Ellume Covid-19 Home Test, the FDA encourages you to request a COVID-19 molecular diagnostic test through your healthcare provider, urgent care, or COVID-19 testing site. Further, the molecular diagnostic test will confirm the positive results. 

Additionally, Ellume is offering a replacement product for unused COVID-19 Home Tests purchased from the affected lot. Visit their website to request a replacement. Alternatively, consumers are also welcome to contact Ellume’s product support team at 1-888-807-1501 (9 a.m. to 5 p.m. ET, Monday through Friday) for a replacement. 

In the meantime, Ellume will continue to remove the affected products from store shelves. Furthermore, the FDA will assist Ellume in determining the reason for the manufacturing issue and will be available to assist with additional manufacturing checks and other corrections.