Pilot COVID-19 At-Home Test

2023: Recall of 2.7 million tests

On May 25, 2023, the US Food and Drug Administration (FDA) announced that the South Korean biodiagnostic company SD Biosensor is forced to recall more than 2.7 million home tests for COVID-19 due to the risk of bacterial infection.

We are talking about the Pilot COVID-19 At-Home Test series, which were distributed by Roche Diagnostics in its own packaging. Tests are permitted for over-the-counter use and the analysis is based on a nasal swab. The procedure can be carried out from the age of two.

Pilot COVID-19 At-Home Test

The FDA's official notice says the liquid solution in the test kit may be contaminated with bacteria such as Enterococcus, Enterobacter, Klebsiella and Serratia. This can cause disease in "people with weakened immune systems or those exposed to direct contact with an infected substance." In addition, the presence of bacteria can affect the effectiveness of the test by provoking false results.

Watch for signs of bacterial infection caused by exposure to an infected liquid solution. If you observe fever, discharge, redness of the eyes, or any other alarming symptoms, seek medical attention, the FDA says on its website.

Infected tests can be identified by the batch number on the outer packaging. All consumers and health facilities are urged to stop using such products immediately and dispose of them along with household waste. The FDA warns that the use of tests can result in serious health problems and even provoke death. However, SD Biosensor has not received any complaints or reports of deaths, health or other adverse events related to the use of Pilot COVID-19 At-Home Test.^[1]

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