|
Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication
Update: The FDA updated this Safety Communication to clarify that the DiaTrust COVID-19 Ag Rapid Tests in the green and white packaging are a product of Celltrion Healthcare.
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).
|
