US FDA Issues 'Use Stop' Warning for Some SD Biosensor Self-Diagnostic Kits

SD Biosensor's COVID-19 Self-Test Kit 'Pilot COVID-19 At-Home Tests'
Photo by SD Biosensor

The U.S. Food and Drug Administration (FDA) has recommended discontinuing the use of certain COVID-19 self-test kits manufactured by SD Biosensor and sold in the United States.

According to industry sources on the 7th, the FDA warned healthcare professionals and consumers to stop using some of SD Biosensor's COVID-19 self-test kits, "Pilot COVID-19 At-Home Tests," due to concerns that the diagnostic reagent may have been contaminated with bacteria.

The FDA explained that direct contact with this reagent raises safety concerns and may also lead to inaccurate test results. They advised seeking medical attention if symptoms such as fever or redness appear after contact.

This kit is a product that SD Biosensor supplied to the U.S. through the global medical device company Roche Diagnostics. It is approved by the Ministry of Food and Drug Safety only for export and is not sold domestically in Korea.

The FDA stated that, together with Roche Diagnostics, they are investigating how many of these products have been sold to consumers, and SD Biosensor has begun recalling the affected products.

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