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Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests - FDA Safety Communication
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to warn consumers and health care providers to stop using and throw out certain lots of SD Biosensor Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics.
The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution provided in the test kit. Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test.
This safety communication provides:
- Recommendations for consumers, test users, caregivers, health care providers, 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).
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