FDA alerts providers to E25Bio COVID-19 Direct Antigen Response Test recall

The Food and Drug Administration today announced a Class 1 recall of the E25Bio COVID-19 Direct Antigen Response Test, which was marketed and distributed to U.S. customers without authorization or approval. Due to the potential for false results, FDA said health care providers who administered the test in the past two weeks and suspect an inaccurate result should consider retesting patients with an authorized test.