The agency warned that the use of these tests may cause serious adverse health consequences or death.
The manufacturing issue did not appear to have affected negative results, according to the FDA.
But those who received a positive result using the Ellume test kit should proceed with caution.
Photo Courtesy of Ellume
Ellume worked with the FDA to voluntarily remove the affected tests from the market.
The company is already producing and shipping new, unaffected test kits to the U.S., the spokesperson said.
Why Is This Error So Dangerous?
Ellumes at-home test isnt the only COVID-19 test that the FDA has removed from the market.
Since the start of the pandemic,268 COVID-19 tests have been removed from the market.
What Should You Do if You Used an Ellume Test?
Anyone who purchased an Ellume test kit at least two weeks ago could be affected by the recall.
Customers can check their products lot number against theFDAs database.
Affected tests that are not yet used will be disabled via a software update.
The company will also inform customers who received a positive result.
To date, the FDA has received 35 reports of false positives and no deaths from the Ellume product.
Check your products lot number against theFDAs database.
Visitwww.ellumecovidtest.com/returnfor more instructions or call 1-888-807-1501 or emailproductsupport@ellume.com.
For the most recent updates on COVID-19, visit ourcoronavirus news page.
U.S. Food and Drug Administration.Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results.
