Nearly 200,000 at-home COVID-19 tests in the United States have been recalled by Australian medical tech manufacturer Ellume after the company identified that they were producing incorrect positive results.
Ellume was given an emergency authorization in December 2020 by the U.S. Food and Drug Administration (FDA) to supply the COVID-19 Home Test for nonprescription use by symptomatic and asymptomatic individuals aged 2 years and older. The home tests deliver results within 15 minutes.
The Biden administration signed a $231.8 million deal with the company, which initially got the green light from the Trump administration in 2020, to produce more than 633,000 tests kits per day (19 million per month), of which 8.5 million units were reserved for Americans.
But the FDA on Oct. 5 stated that it’s “alerting test users, caregivers, health care personnel, and the public of the potential for 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 notice reads.
The FDA added that it’s working closely with Ellume to “assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved.”
In the meantime, 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.
Users are also asked to contact their health care provider or urgent care facility to request a COVID-19 molecular diagnostic test if they have received a positive result with the potentially defective at-home test within the past two weeks, and haven’t yet had a follow-up with a health provider to confirm the positive result.
“You should not assume that you had COVID-19 or have immunity to COVID-19,” the FDA stated, 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 Oct. 6 that 195,000 out of 3.5 million tests that were shipped to the United States had been affected.
Some of the recalled tests were provided to the U.S. Department of Defense, according to a report by The New York Times.
The company said in a statement on its website that it had identified the incidence of false positives in specific lots of the tests following a thorough investigation.
“We offer our 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,” the statement reads.
Ellume is one of several companies that has received emergency use authorization by the FDA for rapid antigen COVID-19 tests, and the recall comes amid growing demand for home tests in support of the Biden administration’s efforts to combat COVID-19.
On Oct. 4, the FDA granted emergency use authorization for ACON Laboratories’ Flowflex COVID-19 Home Test, which can be used at home without a prescription.
ACON, a San Diego-based company, plans to produce more than 100 million tests per month, and 200 million per month by February 2022, the FDA said in a statement.
Caden Pearson contributed to this report.