Ellume at-home tests being made. Photo: Patrick Hamilton/AFP
Ellume, an Australian company that makes at-home COVID-19 tests, is voluntarily recalling test kits sent to retailers and the Department of Defense due to concerns over false positives, the company announced in a statement.
Why it matters: In September, manufacturers warned that the U.S. was weeks away from the production levels needed for President Biden's plan of mass-scale rapid COVID-19 testing.
- The U.S. has been far more cautious than other countries about rapid, at-home testing, AP notes.
By the numbers: About 427,000 test kits have been impacted, according to ABC News.
- 195,000 of those kits were unused and eligible for a recall.
- The remaining kits led to 42,000 positive results and as many as a quarter of the results may have been false positives, Ellume CEO Dr. Sean Parsons said, per the New York Times.
What they're saying: "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.
- "We have learned from this experience, we have implemented additional controls to ensure our product meets our high quality standards and we are going to do everything in our power to regain your trust," Parsons added.