Recall of COVID-19 home tests following false positives

Hundreds of thousands of home COVID-19 tests from Australian digital diagnostics company Ellume were recalled on Tuesday after it was discovered that some tests gave higher than expected false positive results.

The company, also located in Frederick, Md., Announced the voluntary recall of 43 specific lots, or approximately 427,000 tests, of the Ellume COVID-19 home test in an article posted on its website.

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Nearly 200,000 of those tests – the company’s rapid home COVID-19 antigen test – go unused and around 42,000 affected tests have been used with positive results.

The tests had obtained emergency use authorization (EUA) from the United States Food and Drug Administration (FDA).

“There is an increased likelihood that testing of affected lot numbers will give a false positive result. The voluntary recall is carried out after specific product lots report higher false positive test result rates than those seen in clinical trials. Ellume investigated the problem. , identified the root cause, implemented additional controls and we continue to work to resolve the issue that led to this recall, ”said Ellume. “Distribution of Ellume COVID-19 home tests to retail and distribution partners has resumed. “

The affected product was handed over to retailers and distributors from April to August of this year.

The problem was related to a manufacturing problem.

As Ellum removes the product from store shelves, the company has advised those with existing inventory of the lots to cease use and distribution and immediately quarantine the product.

Distributors and retailers who distributed the recalled product are urged to notify any additional accounts or locations that may have received the recalled product from them and distributors and retailers would be contacted by Ellume with specific instructions regarding disposal or the return of the product.

Consumers, Ellume continued, should check whether or not their product was in the affected lots and go to www.ellumecovidtest.com/retour for further instructions.

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Those attempting to use the 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 past 14 days or who used an affected product before September 17, 2021 and tested positive of the voluntary recall via email.

Those who have had any adverse reactions or quality issues with the use of the tests can report their experiences to the FDA’s MedWatch Adverse Event Reporting program online, by mail, or by fax.

“At Ellume, we understand that trust is essential to achieving our goal as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them succeed. manage their health and regain some control of their lives during this pandemic. To these people, I offer my sincere apologies – and our entire company – for any stress or hardship they may have experienced as a result of a false positive result, ”Founder and CEO Dr Sean Parsons wrote in a report.

“You have my personal commitment which we have learned from this experience, we have put in place additional controls to make sure our product meets our high quality standards and we will do everything in our power to regain your trust “, he promised.

In its own article, the FDA said it was working closely with Ellume to assess the company’s additional manufacturing controls and other corrective actions to ensure the issue is resolved.

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The FDA has advised test users and caregivers to check the lot number on the test carton, contact a healthcare provider or COVID-19 testing site if there is a posIpositive test result of one of the affected lots within the last two weeks and the patient has not undergone a follow-up molecular diagnostic test to confirm the result and whether an individual has not received a positive result d ‘another COVID-19 test at the time of the original positive Ellume test result.

Ellume became the first company to obtain an EUA from the FDA to sell consumer kits at major retailers in December 2020. The FDA granted a review of the EUA in February 2021.

The Associated Press contributed to this report.