FDA recalls over 500,000 COVID-19 at-home tests due to bacterial contamination risk.
The FDA has warned consumers and health providers to stop using and discard Pilot COVID-19 At-Home Tests made by SD Biosensor, Inc. due to concerns of bacterial contamination. SD Biosensor is recalling all impacted tests, which were distributed by Roche Diagnostics to various retailers. The FDA said the tests may be contaminated with bacteria such as enterococcus, enterobacter, klebsiella, and serratia species and cause infection. Some 500,000 tests were distributed to CVS Health, as well as about 16,000 tests to Amazon, the FDA said.