At-home COVID-19 tests recalled over false positives
Hundreds of thousands of at-home COVID-19 tests from Australia-based digital diagnostics company Ellume were recalled Tuesday after discovering that some tests delivered higher-than-expected false positive results.
The company, also located in Frederick, Md., announced the voluntary recall of 43 specific lots, or about 427,000 tests, of the Ellume COVID-19 Home Test in a post on its website.
Nearly 200,000 of those tests – the company's rapid, at-home COVID-19 antigen test – are unused and about 42,000 affected tests have been used the produced positive results.
The tests had been granted emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA).
FILE - Image of ellume COVID-19 home test. (ellume)
"There is an increased chance that tests from the affected lot numbers may give a false positive result. The voluntary recall is being taken after specific product lots reported false-positive test result rates higher than was observed in clinical testing. Ellume has investigated the issue, identified the root cause, implemented additional controls and we are continuing to work on resolving the issue that led to this recall," Ellume said. "Distribution of Ellume COVID-19 Home Tests to retail and distribution partners has recommenced."
The affected product was given to retailers and distributors from April through August of this year.
The problem was tied to a manufacturing issue.
While Ellum is removing the product from store shelves, the company advised that those with an existing inventory of the lots should stop use and distribution and immediately quarantine the product.
RELATED: US to increase at-home COVID-19 rapid test availability
Distributors and retailers who have further distributed the recalled product are instructed to notify any accounts or additional locations that may have received the recalled product from them and distributors and retailers will reportedly be contacted by Ellume with specific instructions regarding disposal or return of the product.
Consumers, Ellume continued, should check to see whether or not their product was part of the affected lots and go to www.ellumecovidtest.com/return for further instructions.
Those who attempt to use affected tests will be alerted in the Ellume COVID-19 Home Test app that the test has been recalled and disabled and directed to the same website to request a product replacement.
Ellume will also directly notify consumers who have used an affected product and tested positive in the last 14 days or who used an affected product before September 17, 2021, and tested positive of the voluntary recall via email.
RELATED: At-home COVID-19 test: FDA approves rapid, 30-minute antigen swab kit
Those who had adverse reactions or quality problems with the use of the tests may report their experiences to the FDA's MedWatch Adverse Event Reporting program online or by regular mail or fax.
"At Ellume, we understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and to take back a bit of control of their lives during this pandemic. To those individuals, I offer my sincere apologies – and the apologies of our entire company – for any stress or difficulties they may have experienced because of a false positive result," founder and CEO Dr. Sean Parsons wrote in a statement.
"You have my personal commitment that we have learned from this experience, we have implemented additional controls to ensure our product meets our high quality standards and we are going to do everything in our power to regain your trust," he pledged.
In its own post, the FDA said that it was working closely with Ellume to assess the company's additional manufacturing checks and other corrective steps to ensure that the issue is resolved.
The FDA advised that test users and caregivers, check the lot number on the test carton, contact a health care provider or COVID-19 testing site if there was a positive test result from one of the affected lots in the last two weeks and the patient has not had a follow-up molecular diagnostic test to confirm the result and if an individual did not receive a positive result from a different COVID-19 test at the time of the original Ellume positive test result.
Ellume became the first company to gain an FDA EUA to sell consumers kits at major retailers in December of 2020. The FDA granted a revision to the EUA in February 2021.
The Associated Press contributed to this report. Read more on FOX Business.