FDA: Don’t use antigen test made by Innova Medical Group
![FDA warning](/sites/default/files/styles/900x400/public/2018-04/FDA%20warning.jpg?itok=83PHeMUO)
The Food and Drug Administration yesterday warned health care providers and the public not to use an antigen test for COVID-19 made by Innova Medical Group and distributed under several names. FDA has not authorized or approved the test, which was recalled April 23.
“The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health,” the agency said. Health care providers should destroy or return the test to Innova and consider retesting certain patients if they received the test in the past two weeks, FDA said.
Related News Articles
Headline
The Centers for Disease Control and Prevention's COVID-19 data tracker shows an 18.1% test positivity rate for the week ending Aug. 10, the highest it has been…
Headline
The Centers for Disease Control and Prevention Aug. 13 issued an advisory alerting of an uptick of cases of parvovirus B19 across the U.S. Parvovirus B19 is a…
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),…