After discovering the manufacturing error that caused the false positives, Ellume recalled some antigen tests performed at home.Photo Credit: Elum
After discovering that more Covid-19 tests were affected by manufacturing issues, Ellume expanded the recall of its Covid-19 tests.The company is 2.2 million recalled Due to the higher than the acceptable false positive rate, the Covid-19 antigen test conducted at home, According to the Food and Drug Administration.
Ellume first began its recall on October 5 when it discovered a manufacturing problem. Today, the FDA classifies this recall as a level 1, which is its most serious level.
The FDA stated that if there is a false positive or a test erroneously shows that someone has Covid-19, people may miss a diagnosis of the actual cause of the person’s disease. It may also cause people to receive unnecessary Covid-19 treatment or isolation, and may result in loss of school or work.
So far, 35 false positives have been reported to the agency.
“The Ellume team sincerely apologizes for the pressure or difficulties people may encounter due to false positive results. We have and will continue to work hard to ensure test accuracy in all cases,” Ellum said in an email statement to MedCity News Write.
Ellume received emergency use authorization for home testing in December. Users wipe their noses and then insert samples into the analyzer, which connects with a smartphone app to show people their results. It can also report test results to public health agencies, and users can enter their date of birth and zip code.
Brisbane Australia Company Won a $232 million contract 8.5 million tests from the Ministry of Health and Human Services, and Start to build a manufacturing plant In Maryland earlier this year.
The affected tests are distributed between April 2021 and August 2021. According to the FDA, Ellume has notified the store to remove the affected test from the shelf, and individual consumers can check whether their test is affected by checking the batch number. FDA’s medical device recall database entry.
The company stated that it has investigated the problem, determined the root cause, implemented additional controls, and is producing new products and shipping them to the United States
