Ellume has recalled its at-home coronavirus test due to potential false positive results, according to the U.S. Food and Drug Administration (FDA).
The agency classified the move as a Class I recall, which is the most serious kind, adding the use of the tests may cause serious health problems or death, KRON reported Thursday.
Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Ellume recalls #COVID19 Home Test for potential false positive SARS-CoV-2 test results. Find out more: https://t.co/trYCnubKH7 pic.twitter.com/L6xqzFXk8G
— FDA Medical Devices (@FDADeviceInfo) November 10, 2021
“The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older,” the FDA said in its announcement:
The Ellume COVID-19 Home Test is available without a prescription for use by people with or without COVID-19 symptoms. This at-home test uses swab samples taken from further up inside the nose (mid-turbinate) but not as deep inside the nose to reach the back of the throat (nasopharyngeal) where a health care professional collects a sample. The Ellume COVID-19 Home Test uses an analyzer that connects with a smartphone app to show users how to perform the test and understand the test results.
Ellume is recalling specific lots of the coronavirus tests because they had a higher-than-acceptable false positive results for the coronavirus, the agency continued, adding “The reliability of negative test results is not affected.”
In regard to the tests, a false positive result showed an individual had the virus when they did not have it.
This could lead to delayed diagnosis or treatment for the actual cause of the person’s sickness, further spread of the virus, or the individual receiving unnecessary coronavirus treatment from health care professionals.
“There have been 35 reports of false positive results sent to the FDA and no deaths reported,” the agency said.
In October, Ellume recalled some at-home tests when it learned they reported a higher-than-expected rate of false positive results.
“The company said about 427,000 tests are in the lots identified in the recall, and nearly 200,000 are unused. Ellume said tests from those lots may provide false positive results at a rate higher than researchers saw during clinical testing,” the Associated Press (AP) reported at the time.