Stocking up on COVID-19 self test kits is essential now that school is in full swing. At-home COVID test kits can be a useful, convenient, and reassuring way to help families cope with the ongoing pandemic. They work only if they work.

You may want to make sure that your home test for COVID-19 is not part of the Ellume recall if you have recently purchased one. The U.S. Food and Drug Administration issued a warning on October 5th that some Ellume COVID-19 home tests may give false positive results.

Potential False Positives With Ellume COVID-19 Antigen Test

Ellume reports on its website that the home rapid COVID-19 test was voluntarily recalled. According to Ellume, false-positive results are more common in tests from affected lot numbers. According to Ellume, a test result could indicate that someone has the COVID-19 virus but they are not. FDA says that the manufacturing problem doesn't seem to have affected negative results.

Ellume's website shows that the COVID-19 Home Testing Kits were sold by many national retailers. The recall affected Ellume COVID-19 home test kits were distributed between April 2021 and September 2021.

To determine if your kit has been affected by the recall, compare the lot number on your test carton with the Ellume lot numbers. The FDA offers additional suggestions for individuals who have used the affected tests and received positive results.

Recommendations for Ellume Test Users

Consult a healthcare provider if you have been positive for Ellume COVID-19 Home Tests from any of the affected lots within the past two weeks. It is possible for the result to be positive.

The FDA encourages you, if you have received positive results from an Ellume Covid-19 home test, to request a COVID-19 molecular diagnostic testing through your doctor, urgent care or COVID-19 testing location. The positive results will be confirmed by the molecular diagnostic test.

Ellume also offers a replacement product to COVID-19 Home Testing results that were not used from the affected lot. To request a replacement, visit their website. Ellume's customer support team can be reached at 1-888-807-1501 between 9 a.m. and 5 p.m. ET Monday through Friday) to request a replacement.

Ellume will continue to take affected products off the shelves. The FDA will also assist Ellume with determining the cause of the manufacturing problem and will be available for additional manufacturing inspections and corrections.

-----------------------------------

By: Brittany Baxter
Title: COVID-19 Home Test Being Recalled For Possible False Positive Results
Sourced From: www.suggest.com/ellume-covid-19-home-test-recall-october-2021/2596477/
Published Date: Sat, 30 Oct 2021 21:45:00 +0000

Read More