(CMR) Ellume has issued a voluntary recall of nearly 200,00 rapid antigen test kits over concerns about a higher than expected rate of false positives earlier on Tuesday. Retailers have been asked to remove the affected kits off the shelves and consumers will be notified via the app that it has been recalled.
The U.S. Food and Drug Administration immediately alerted test users, caregivers and health care personnel of the issue with the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue.
The FDA shared that they are working closely with the Australian company to identify any other areas of concern with the manufacturing checked and assist with any necessary corrective steps to resolve the issue. The issue was dedicated in mid-September and traced to variations in the quality of one of the raw materials used.
Some 427,000 test kids were affected by the problem with half of them already being used and resulting in 42,000 positive results. It is estimated that as many a quarter of those positives may have been inaccurate. The kits in question account for 5.6% of the approximately 3.5 million tests kids Ellume has shipped to the United States. Some of those were provided to the U.S. Department of Defense.
The company said that it did not affect all Ellume test kids or the reliability of negative results.
In December this test became the first available over-the-counter completely at home test to receive emergency use authorization from the FDA. The rapid antigen test is designed to detect pieces of the virus in the nose. Users swab their nostrils, insert the swab into a dropper of fluid and then add the fluid to a Bluetooth-connected analyzer. Results are transmitted to a smartphone app in 15 minutes.
Consumers impacted by the recall can request a replacement online and unused kits have been rendered unusable. The company noted that they have put “extra controls” in place to prevent the issue from happening again.
“We are doing everything possible to get known, good product into the hands of consumers in the U.S”.
Dr. Sean Parson, Ellume's CEO
There has been a shortage of available at-home tests but on Monday the FDA authorized another at-home antigen test from ACON Laboratories Flowflex which should ease some of the supply and demand issues. They noted that this should double the rapid at-home testing capacity in the U.S. over the next several weeks.