November 12, 2021
Life Sciences
  • The FDA announced the recall of more than 2 million at-home COVID-19 tests produced by Ellume due to “higher-than-acceptable” false positive test results. The FDA says there have been 35 reports of false positives, enough for the agency to identify it as a Class I recall – the most serious kind. However, there have been no deaths related to the test failures, and the reliability of negative test results is not affected. (Articles here, here, here, and here)