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Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication
https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-sd-biosensor-pilot-covid-19-home-tests-fda-safety-communication
Date Issued: May 4, 2023
The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers to stop using and throw out certain lots of recalled 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. SD Biosensor, Inc. hasinitiated a recallfor all impacted SD Biosensor Pilot COVID-19 At-Home Tests that were distributed by Roche Diagnostics to certain retailers in the United States. Approximately 500,000 tests were distributed to CVS Health, as well as about 16,000 tests to Amazon. The FDA is working with Roche Diagnostics to understand how many of those tests were sold to consumers.
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