An Australian company is the latest to recall at-home Covid testing kits that are being used in the United States. Medical manufacturer Ellume made the emergency move saying the 200,000 tests produce an incorrect positive result.
Critics say the Australian tests, as well as others purchased from China and Europe, could be one reason for spikes in Covid that may not actually be happening. Over 3.5 million of the company’s kits have already been used in the United States.
The Biden administration signed a $231.8 million deal with the company, which initially got the green light from the Trump administration last year, to produce over 633,000 tests kits per day (19 million per month), of which 8.5 million units were reserved for Americans. The tests can be used by symptomatic and asymptomatic individuals aged 2 years and older and deliver results within 15 minutes.
But the FDA on Tuesday said it is “alerting test users, caregivers, health care personnel, and the public of the possible false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue.”
“For these tests, a ‘false positive’ is a test result that indicates that a person has the virus when they do not actually have it. Negative results do not appear to be affected by the manufacturing issue,” the FDA notice reads.
Test users are being asked to check if their home tests are included in the recall by comparing the lot number on the test carton to the lot numbers on the company’s website.
“You should not assume that you had COVID-19 or have immunity to COVID-19,” the FDA said, while recommending at-home test users still take precautions in line with the Centers for Disease Control and Prevention recommendations.
A spokesman for Ellume told AFP on Wednesday 3.5 million tests were shipped to the United States and some were provided to the U.S. Department of Defense, according to a report by The New York Times.
The revelation of the false-positive results from the tests is adding to doubts about the spikes of Covid that continue to shutter schools and guide policy-making decisions by health departments.