The U.S. Meals and Drug Administration announced the recall of 2.2 million home COVID-19 tests made by Ellume due to “higher-than-acceptable false positive test results.” Ellume, the primary firm to get FDA approval for over-the-counter COVID tests, had final month for a similar situation.
About 35 false positives by the Ellume COVID-19 Home Take a look at had been reported to the FDA, with no deaths reported, the company stated. However false positives may lead to destructive outcomes resembling getting unneeded COVID-19 therapy from a well being care supplier or a delayed prognosis for the particular person’s precise sickness, the FDA added.
The FDA stated that the reliability of destructive take a look at outcomes aren’t impacted by the problem. However individuals who have purchased an Ellume home COVID-19 take a look at ought to examine the product by coming into the lot quantity at this Ellume website, which is able to decide whether or not the buyer has one of many impacted tests. The lot quantity is discovered on a sticker on the aspect of the product carton.
If a client obtained a constructive take a look at inside the final two weeks by utilizing one of many affected tons, they need to contact their well being care supplier, the company stated.
The “incidence of false positives is limited to specific lots,” Ellume CEO Dr. Sean Parsons stated in a statement. He additionally apologized to individuals who obtained false positives by the take a look at equipment “for any stress or difficulties they may have experienced.”
The FDA stated the Ellume case is a Class I recall, which it stated is probably the most severe sort. “Use of these tests may cause serious adverse health consequences or death,” the company stated within the assertion.
The recall comes at a time when. Many pharmacies are out of inventory, and if they’re obtainable, the tests will price about $24 a pair — an costly outlay for a lot of customers who want frequent testing.
Whereas many customers would undoubtedly like to have the ability to take a look at for COVID-19 at home, the shortages and prices imply that many examine their well being standing solely when touring or attending a particular occasion. However which will change within the subsequent few months, with the Biden administration in September saying it might make investments $1 billion to broaden the provision of at-home COVID-19 tests.
The Ellume COVID-19 Home Take a look at is an antigen take a look at that works by detecting proteins from the SARS-CoV-2 virus, which causes COVID-19. The over-the-counter take a look at requires customers to swab the within of their noses.
The FDA stated the recalled home tests had been manufactured between February 24 to August 11, and distributed between April 13 to August 26.