Roche-Labeled COVID-19 At-Home Tests See Class I Recall for Contaminated Liquid

The FDA has deemed the recall of certain lots of the SD Biosensor Pilot COVID-19 at home tests, distributed and packaged by Roche Diagnostics, as Class I, the most serious type of recall, because of potential bacterial contamination of the liquid solution in the test kit.

SD Biosensor, the manufacturer, initiated the recall on March 31, after finding that the liquid solution in the test kit may be contaminated with bacteria such as enterococcus, enterobacter, klebsiella and serratia. The bacteria may cause illness in people with weakened immune systems or with direct exposure to the contaminated liquid solution and may affect the accuracy of the test.

Since use of the affected product may cause serious adverse health consequences or death, SD Biosensor advised consumers to immediately stop using the test, and dispose of the tests in household trash.

Importantly, none of the impacted lots were distributed through COVID.gov/tests - Free at-home COVID-19 tests or as part of other federal testing programs.

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