The US Food and Drug Administration (FDA) has warned that certain batches of the Ellume COVID-19 Home Test may be giving false positive results due to a manufacturing error.
The company voluntarily recalled specific lots of its rapid, at-home Covid-19 antigen test, which was granted Emergency Use Authorization (EUA) in December 2020. The rapid antigen test uses nasal swab samples to diagnose Covid-19 with a Bluetooth-connected analyser, which transmits the results of the test to an associated smartphone app within 15 minutes. It was the first over-the-counter, completely at-home rest to receive EUA.
The nearly 200,000 test kits Ellume has subject to recall make up approximately 5.6% of the 3.5 million test kits Ellume has shipped to the US, with about 427,000 test kits affected by the problem overall.
The test kits that have already been used have yielded about 42,000 positive results, as many as a quarter of which may have been inaccurate.
The Ellume recall was initiated after higher numbers of false-positive results were reported about the test than were observed during laboratory development.
Ellume said it has identified the root cause of the issue and is working on resolving it, and that distribution of the tests has resumed. The issue was traced to variations in quality of one of the raw materials used in the test kit.
The affected tests were distributed to retailers between April and August 2021, and all customers who received them are able to request a product replacement.
Customers who used an affected test and tested positive within the last two weeks will be directly contacted by Ellume and informed about the recall. Those who attempt to use the affected tests will be alerted by Ellume’s app.
The FDA has advised that all those who received a positive result from an Ellume test affected by the error within the past two weeks should undergo a molecular diagnostic test for Covid-19 to confirm the result.
Consumers are also advised to contact their healthcare providers if they received a positive result from an affected Ellume test more than two weeks ago and did not receive a positive from a different test at the time. They have been advised not to assume they have had Covid-19 or have immunity to the disease.
The error does not appear to have led to the generation of any false negative results.
Ellume CEO and founder Dr Sean Parsons said: “At Ellume, we understand that trust is central to fulfilling our purpose as a company, and we recognise 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.”
This isn’t the first lateral flow test (LFT) to be recalled in the US. Back in June, the FDA recalled the LFT developed by Innova Medical Group, the main LFT available in the UK at the time.
After the agency advised US citizens to throw out the Innova test, UK regulators caused some controversy when they extended the authorisation of the Innova test by another several months.