- The FDA recalled 2 million Ellume at-home COVID-19 tests, about fives times more units that were in the company's original recall from October.
- The tests can give people false-positive results for the coronavirus.
- So far there have been 35 recorded false-positive tests sent to the FDA and no recorded deaths.
The Food and Drug Administration has vastly expanded the recall of Ellume at home COVID-19 testing kits over false postive results, now classifying it as its most serious type of recall.
The number of recalled tests has grown to more than 2.2 million, up from the 427,000 tests that were included in the company's voluntary recall issued in October. The FDA reclassified the recall on Wednesday, stating that "use of these tests may cause serious adverse health consequences or death."
False-positive COVID-19 tests can be dangerous, according to the FDA. Those who are sick and receive a false positive test for coronavirus can put themselves further at risk for not receiving proper treatment for their actual illness. False-positive results can also lead to the further spread of COVID-19 when presumed positive people quarantine together, isolation from friends and family, disregard for the recommended precautions against COVID-19, and adverse side effects from any treatment they receive for COVID-19, the FDA states with the recall.
So far there have been 35 recorded false-positive tests sent to the FDA and no recorded deaths. Negative tests results do not appear to be affected by the manufacturing issue.
"Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.," a spokesperson told Insider in a statement. "The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false-positive result."
Ellume was the first company authorized by the FDA to sell COVID-19 testing kits in stores. The rapid test kits provide results within 15 minutes and do not require a prescription. In clinical studies, Ellume tests were 96% accurate, according to data from the company.
The recalled tests were manufactured from February 24 to August 11, 2021, and shipped to retailers between April 13 and August 26, 2021. At the start of the voluntary recall on October 1, Ellume reached out to its customers who tested positive before September 17 to notify them that their results could have been incorrect. All affected tests have been removed from pharmacy shelves and online stores, but purchasers of Ellume tests can see if their device was included in the recall by visiting Ellume's recall website.
In August, CVS had to limit the sale of Ellume's tests due to demand caused by the surge of the Delta variant.