A maker of fast Covid checks remembers practically 200,000 kits over considerations of false positives.

Ellume, an Australian firm that makes a extensively accessible at-home coronavirus check, has recalled practically 200,000 check kits due to considerations a few higher-than-expected charge of false positives. That represents about 5.6 p.c of the roughly 3.5 million check kits Ellume has shipped to the US.

The corporate, which detected the issue in mid-September, traced the problem to variations within the high quality of one of many uncooked supplies used within the check package, Dr. Sean Parsons, Ellume’s chief government, stated in a telephone interview. He declined to specify the fabric in query, citing a need to not publicly disclose exactly how the check kits work.

About 427,000 check kits, together with some offered to the U.S. Division of Protection, had been affected by the issue, Dr. Parsons stated. Roughly half have already been used, he stated, yielding about 42,000 constructive outcomes. As many as 1 / 4 of these positives might have been inaccurate, Dr. Parsons stated, though he burdened that it could be tough to find out precisely what number of.

“I’m very sorry that this has occurred,” Dr. Parsons stated. “We’re all about chasing accuracy, and to have these false positives is disappointing.”

The problem didn’t have an effect on all Ellume check kits or the reliability of adverse outcomes, the corporate stated.

Ellume’s check is a fast antigen check, designed to detect items of the virus within the nostril. Customers swab their nostrils, insert the swab right into a dropper of fluid after which add the fluid to a Bluetooth-connected analyzer. Outcomes are transmitted to a sensible telephone app in quarter-hour. Final December, it grew to become the first over-the-counter, completely at-home test to obtain an emergency use authorization from the U.S. Meals and Drug Administration.

The corporate has requested retailers to take away the checks from cabinets and is within the technique of notifying customers, Dr. Parsons stated.

Shoppers who’ve one of many affected checks can request a replacement on-line. Individuals who attempt to use one of many affected check kits can be notified within the app that the check has been recalled. “It actually gained’t be potential to make use of any of these checks now,” Dr. Parsons stated.

He added that the corporate had put “further controls” in place to stop the identical downside from cropping up once more sooner or later.

“We’re doing the whole lot potential to get identified, good product into the palms of customers within the U.S.,” Dr. Parsons stated.

The recall comes as demand for testing has soared, and customers have complained that at-home check kits are arduous to search out.

On Monday, the F.D.A. licensed a brand new at-home antigen check, ACON Laboratories’ Flowflex. The authorization “is predicted to double fast at-home testing capability within the U.S. over the following a number of weeks,” Dr. Jeffrey E. Shuren, who directs the F.D.A.’s Heart for Units and Radiological Well being, stated in a statement. “By 12 months’s finish, the producer plans to supply greater than 100 million checks per 30 days, and this quantity will rise to 200 million per 30 days by February 2022.”