Almost 200,000 Ellume COVID-19 home testing kits have been recalled because they may be more likely to give a false positive result.
The problem with the rapid antigen tests was identified in mid-September and caused by variations in the quality of one of the raw materials used in the products, Ellume CEO Dr. Sean Parsons told The New York Times.
The Ellume test kits received emergency use authorization from the U.S. Food and Drug Administration last December, and the Australian company had already shipped about 3.5 million of the test kits to this country.
About 427,000 of those kits were affected by the problem, and about half have already been used, returning about 42,000 positive results, Parsons told the Times.
He said it would be difficult to determine how many of those positive results may have been incorrect, but said the rate could be as high as one quarter.
The issue with the recalled test kits doesn't affect the reliability of negative results, according to the company.
Ellume's test is designed to detect pieces of the virus in the nose. After swabbing the nostrils, the swab is inserted into a dropper of fluid, and the fluid is then added to a Bluetooth-connected analyzer. Results arrive via a smart phone app in 15 minutes.
The company said it has asked retailers to stop selling the recalled kits and has notified consumers about the issue.
Consumers should go to the Ellume website to see if their home test kit is included in the recall and to get instructions on what to do if it is, the company said.
To arrange a replacement, consumers can call Ellume at 1-888-807-1501, 9 a.m. to 5 p.m. ET, Monday through Friday.
People who try to use one of the affected test kits will be notified in the app that the test has been recalled, Parsons explained. "It really won't be possible to use any of those tests now," he added.
He noted that the company had put "extra controls" in place to prevent the same problem from happening again in the future.
"I'm very sorry that this has happened," Parsons told the Times. "We're all about chasing accuracy, and to have these false positives is disappointing."
The recall comes as demand for at-home testing has soared, and consumers have complained that test kits are hard to find, the Times reported.
On Monday, a new at-home antigen test from ACON Laboratories was approved for emergency use by the FDA.
That approval "is expected to double rapid at-home testing capacity in the U.S. over the next several weeks," Dr. Jeffrey Shuren, who directs the FDA's Center for Devices and Radiological Health, said in a statement. "By year's end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022."
"Since March 2020, the FDA has authorized more than 400 COVID-19 tests and sample collection devices, including authorizations for rapid, OTC at-home tests," Shuren added. "The FDA considers at-home COVID-19 diagnostic tests to be a high priority and we have continued to prioritize their review given their public health importance."