December 9, 2021

FDA Recalls Millions of Ellume At-Home COVID-19 Tests After Reports of False-Positive Results

The Meals and Drug Administration (FDA) has issued a recall of hundreds of thousands of at-home COVID-19 assessments after experiences of false-positive outcomes.

Greater than 2.2 million at-home Rona assessments, created by digital diagnostics agency Ellume, needed to be recalled this week after the FDA obtained 35 experiences of false-positive take a look at outcomes. Fox Enterprise experiences the recall needed to be categorised as a “class 1” recall, which is probably the most extreme sort of recall as a result of of the chance of “serious adverse health consequences or death.”

The take a look at entails a much less invasive nasal swab than those well being gives use; the take a look at sees proteins from the SARS-CoV-2, the information outlet experiences. The recall comes after the corporate discovered a “manufacturing issue” final month.

The FDA stated the false-negative outcomes folks obtain from the assessments are dependable as they weren’t affected by the manufacturing challenge. “Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,” a spokesperson for the corporate informed FOX Enterprise on Thursday. They talked about that the malfunction had been fastened.

“The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false-positive result. We have and will continue to work diligently to ensure test accuracy, in all cases,” they continued.