Ellume is advising test users to check if their product is part of the affected lot. If it is, they should visit www.ellumecovidtest.com/return, call 1-888-807-1501 or email firstname.lastname@example.org.
To check if a test is part of the affected lots, visit the Medical Device Recalls website to compare lot numbers. Lot numbers are posted on a sticker on the side of the Ellume tests.
Test users should also contact their health care provider, urgent care facility or other COVID-19 testing site to request a COVID-19 molecular diagnostic test to confirm a positive result.
The antigen test uses a nasal sample to detect proteins from the SARS-CoV-2 virus, according to the FDA. The test is available without a prescription and can be used by people with or without COVID-19 symptoms. The home test reportedly uses an analyzer that connects with a smart phone app to show people how to use the test and understand the results.
The FDA issued an emergency use authorization for the Ellume COVID-19 Home Test on Dec. 15 and authorized a revision on Feb. 11 to allow emergency use of the test.