US FDA advises disposal of SD Biosensor’s Covid

SD Biosensor, an in vitro diagnostic firm, is facing trouble at home and abroad.

In April, the National Tax Service slapped a fine of about 100 billion won ($74.6 million) on SD Biosensor, and the U.S. Food and Drug Administration recently recommended suspending the use of the company's Covid-19 diagnosis kits at home, citing problems with its quality.

On May 4 (local time), the U.S. FDA recommended discarding or suspending the use of parts of SD Biosensor's at-home Covid-19 diagnostic kits with specific manufacturing process (lot) numbers. FDA said problems, including concerns over bacterial infection, occurred in the reagent of SD Biosensor's Pilot COVID-19 At-Home Test distributed by Roche Diagnostics.

Accordingly, SD Biosensor has begun to recall the diagnostic kits Roche had distributed in America. About 500,000 such kits have been distributed to CVS Health, and 16,000 others were distributed to Amazon.

FDA is checking how many such kits were sold to consumers in collaboration with Roche.

The products in question have 44 lot numbers, including 53K38N1T1, 53K4221T1, and 53K4292T1.

The U.S. regulator said it found infections by germs, such as Enterococcus, Enterobacter, Klebsiella, and Serratia, in the reagent of these products in question.

The FDA, noting that the reagents themselves are contaminated, advised users not to m also told them not to pour the liquid solutions into the drain but dispose of them as general waste.

"If you are exposed to the reagent and show signs of bacterial infections, such as fever, secretion, and bloodshot, you should see doctors," it said. "If you used the product within two weeks ago, the result may not be correct."

Right after the FDA's recommendation, SD Biosensor released data on discarding or suspending the use of Pilot COVID-19 At-Home Test kits, recalling them, and carrying out acts concerning the FDA's recommendation, the company said.

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