Ellume is recalling nearly 200,000 rapid at-home antigen tests out of concerns over an abnormally high rate of false positives.
Roughly 427,000 test kits, including thousands sent to retailers and some provided to the Department of Defense, were impacted. About 195,000 of these kits are still unused and subject to the recall, and about 202,000, have already been used. Of those, there were about 42,000 positive results, of which as many as a quarter, or perhaps fewer, of those positives could have been inaccurate, though it’s difficult to determine an exact ratio.
CEO Sean Parsons said in a statement, “I offer my sincere apologies — and the apologies of our entire company –for any stress or difficulties they may have experienced because of a false positive result,” Parsons said.
Ellume said it identified the root cause as an issue in variation with one of the kit’s components. The company said it has “implemented additional controls” and is “continuing to work on resolving the issue that led to this recall.”
Ellume is notifying affected customers and urging confirmatory tests.
-ABC News’ Sasha Pezenik
