A recent CBS News article discussed the latest COVID-19 test recall. This time it’s Ellume’s over-the-counter antigen test that has a high rate of false positive test results. The recall includes 2.2 million home tests, and is an expansion of last month’s recall that affected 200,000 that were experiencing the same issue. The FDA has received 35 reports of false positives from Ellume tests, but the agency noted the reliability of negative test results is not affected by the issue. According to a statement from the company, it has identified the root cause of the problem and implemented additional controls to prevent further issues on new lots.
Another COVID-19 Test Recall Over False Positives
More than 2 million home tests were recalled for “higher-than-acceptable false positive test results.”