FDA MedWatch - Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) issued a safety communication warning people not to use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging (see image below). The test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test. This safety communication provides: Recommendations for test users, caregivers, health care personnel, and testing program organizers. Details on the issue and the FDA's actions to address the issue. Instructions for reporting problems with tests to the FDA. Questions? If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE). Read More

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to edwardlorilla1986.paxforex@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA