It’s time to stock up on COVID-19 self testing kits now that the school year has begun. 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.
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. A StatementThe U.S. Food and Drug Administration released warnings on October 5th that some Ellume COVID-19 home test lots could produce false-positive results.
Potential False Positives With Ellume COVID-19 Antigen Test
Ellume’s WebsiteAccording to reports, the COVID-19 rapid antigen test was voluntarily recalled at home. Ellume says that tests from affected lot numbers are more susceptible to false-positive results. The test can result in an individual receiving a “false positive”They are falsely claiming they have the COVID-19 disease. 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. The recall affected Ellume COVID-19 home test kits were distributed between April 2021 and September 2021.
Compare the lot numbers on the test carton to the lot number. Ellume’s websiteCheck to determine if your kit has been affected by the recall. The FDA offers additional suggestions for individuals who have used the affected tests and had positive results.
Recommendations For Ellume Test Users
Talk to your healthcare provider if you have taken an Ellume COVID-19 home test from one of the affected lots during the last two weeks and were positive. It is possible for the result to be positive.
If you receive a positive test result for one of the Ellume Covid-19 Homes Test lots, the FDA encourages that you request a COVID-19 diagnostic test through your healthcare provider or urgent care. The positive results will be confirmed by the molecular diagnostic test.
Ellume also offers a replacement product to COVID-19 Home Testing purchased from the affected lot. Visit their site. WebsiteTo 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 to Friday) to get a replacement.
Ellume will continue to take affected products off the shelves. Additionally, Ellume will continue to remove affected products from store shelves. The FDA will help Ellume determine the source of the manufacturing issue. They will also be available to assist in additional manufacturing checks or other corrections.