May 30, 2023

FDA: Class I recall of certain SD BioSensor Pilot COVID-19 At-Home Tests

Editor's Note

The Food and Drug Administration (FDA), on May 25, identified the recall by SD BioSensor, Inc, of certain Pilot COVID-19 At-Home Tests as Class I, the most serious.

The recall was initiated because the liquid solution in the test kit may be contaminated with bacteria such as Enterococcus, Enterobacter, Klebsiella, and Serratia.

The test kits were distributed by Roche Diagnostics in US Roche packaging. Distribution dates were August 2022 to March 2023.

The company has received no complaints or reports of injuries, deaths, or adverse events related to this issue.


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