Nearly 200,000 COVID Tests Recalled After Kits Produced Huge Number of False Positives
Over the past year and a half, many people around the world have experienced the nerves and annoyance that come with getting a positive COVID-19 test result.
In order to make the process more convenient, some have opted to take an at-home rapid test to avoid the extra hassle of waiting at their local health clinic.
Yet one brand of these tests potentially misled thousands of people.
About 195,000 at-home rapid COVID-19 test kits are being recalled by the Australian technology company Ellume for their high percentage of false-positive results, ABC News reported Wednesday.
Out of the 202,000 kits that have been used by consumers, there have been 42,000 positive results, the outlet reported.
About a quarter of those positive tests — more than 10,000 — are presumed to be false, according to ABC News.
Ellume is recalling nearly 200,000 rapid at-home COVID-19 antigen tests out of concerns over an abnormally high rate of false positives observed from certain lots of its tests. https://t.co/gpjoLkStro
— ABC News (@ABC) October 7, 2021
People likely called out sick for work, school and other commitments for several days to quarantine because of a defective product.
Ellume CEO Sean Parsons released a statement about the voluntary recall in which he admitted his company’s error.
“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,” Parsons said.
“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,” he said.
Parsons said his company is working on making improvements to the test kits in order to prevent the issue from occurring in future lots.
“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 said.
“At Ellume, we remain absolutely committed to developing high-quality digital diagnostics that can be relied on in a health crisis,” Parsons said. “Patient well-being and product quality are our first priorities throughout every step of the manufacturing and supply chain process. We understand you are counting on us to do nothing less.”
The company said it had not run into an issue of false negatives, meaning that this error would only send people into isolation without reason.
About 427,000 of these kits, recalled and not, were distributed to the public retailers and the Department of Defense, according to ABC News.
Over 50% of COVID transmission happens with NO SYMPTOMS.
Rapid testing is key because it detects virus in everyone (not just with symptoms)
What happens when there’s a false positive? I joined @nbcnews @joefryer on the latest recall news: pic.twitter.com/60Lz4yuROG
— Dr. Aditi Nerurkar, MD MPH (@draditinerurkar) October 6, 2021
This recall should encourage people to get a second test if the first one is positive, especially with this form of rapid testing, and especially if their symptoms are nonexistent or minimal.
Ellume was correct to be transparent with the public about the problem and recall its product.
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