More than 200,000 of Ellume tests from affected lots have already been used.
The drug maker is asking for emergency FDA authorization for its antibody treatment to help prevent COVID-19, which would help prevent disease for high-risk Americans with compromised immune systems.COVID-19 antigen 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.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.
Meanwhile, Ellume is notifying consumers, retailers and distributors affected by the recall. It's warning those consumers who have tested positive to take confirmatory tests, as their initial Ellume results may have been incorrect. "We understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and to take back a bit of control of their lives during this pandemic," Parsons said in a statement.
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