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
Pfizer today said its COVID-19 vaccine will receive a priority review from the Food and Drug Administration, indicating that Pfizer has completed its…
Headline
The Food and Drug Administration today revoked its emergency use authorization for the Curative SARS-Cov-2 Assay test because the manufacturer has…
Headline
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will convene July 22 to discuss a pair of recent issues related…
Headline
Johnson & Johnson yesterday was notified that the Food and Drug Administration now will require that the company add to the label of its COVID-19…
Headline
Responding last month to an AHA letter, the Centers for Medicare & Medicaid Services said it will continue to remain flexible in its approach to surveys if…
Headline
The Food and Drug Administration July 2 authorized for emergency use one more batch of drug substance for the Janssen (Johnson & Johnson) COVID-19 vaccine…