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. 

Related News Articles

Headline
Adults age 65 and older are encouraged to receive an updated dosage of the COVID-19 vaccine, the Centers for Disease Control and Prevention announced April 25…
Headline
Paxlovid may no longer be distributed with an emergency use label after March 8, the Food and Drug Administration announced. Providers may dispense unexpired…
Headline
The Food and Drug Administration’s independent Nonprescription Drugs Advisory Committee Sept. 12 by unanimous vote declared oral phenylephrine…
Headline
The Senate Health, Education, Labor and Pensions Committee today 17-3 to pass as amended the Pandemic and All-Hazards Preparedness and Response Act (S. 2333),…
Headline
The Food and Drug Administration’s vaccine advisory committee June 15 voted unanimously to recommend updating the current COVID-19 vaccine composition for…
Headline
The first data on the safety of a third mRNA COVID-19 vaccine dose among young children show that a third dose is safe for children ages 6 months to 5 years…