Nearly 200,000 COVID Tests Have Been Recalled Due to False Results
Ellume is recalling nearly 200,000 rapid at-home COVID-19 antigen tests out of concerns over an abnormally high rate of false positives observed from certain lots of its tests.
Roughly 427,000 test kits, including thousands sent to retailers and some provided to the Department of Defense, have been impacted by the issue.
About 195,000 of these kits are still unused and subject to the recall. About 202,000 have already been used, the company said. Of those, there have been around 42,000 positive results, of which as many as a quarter of those positives could have been inaccurate. However, the company said it’s difficult to determine an exact ratio.
Ellume is removing the affected product from store shelves and said distributors should cease distribution and quarantine those products immediately.
This recall yanks hundreds of thousands of rapid COVID-19 tests off the shelves at a time when demand for these tests has already skyrocketed. Amid shortages, many of the major retail pharmacy stores announced they are limiting purchases to contend with supply constraints. (Read more from “Nearly 200,000 COVID Tests Have Been Recalled Due to False Results” HERE)
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