FDA suspends COVID-19 diagnostic kit of S.Korea’s SD Biosensor

The US Food and Drug Administration (FDA) has recommended that consumers discard select models of Pilot COVID-19 self-diagnostic test kits sold on the American market by South Korea's SD Biosensor Inc..

In a notice on Thursday, the watchdog warned that the solution in the kit may be infected with bacteria and released 44 lot (production process) numbers of the items in question.

Contaminated products could result in misleading diagnoses such as false negatives or positives, the FDA said, and it can cause disease in people with weak immunity. If symptoms of fever, conjunctivitis or other systemic bacterial infections appear in a user of the kit, immediate medical attention was recommended.

“The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the SD Biosensor Pilot COVID-19 At-Home Test to date,” it added.

CVS Health and Amazon have distributed about 516,000 of the pilot tests in the US, the notice said. SD Biosensor in 2021 received emergency approval for the kit’s use and has sold it on the American market through the global medical device company Roche Diagnostics.

The FDA is also mulling the kit’s recall, saying, “The FDA is currently reviewing the SD Biosensor Pilot COVID-19 At-Home Tests recall and is in the process of classifying the recall risk. The FDA is continuing to work with SD Biosensor Inc. to assess the company’s corrective actions to address the reason for bacterial contamination and help ensure the situation is resolved and will not return.”

Write to Hyun-Ah Oh at 5hyun@hankyung.com