FDA flags bacteria risk for 500K COVID-19 tests

The FDA issued a warning May 4 about more than 500,000 COVID-19 tests made by SD Biosensor and distributed by Roche Diagnostics because of "significant concerns of bacterial contamination."

SD Biosensor initiated a recall, and the FDA is currently identifying the risk as consumers are told to discard the tests. Half a million were distributed to CVS Health and 16,000 to Amazon, the FDA said. 

The liquid solution in the tests may be contaminated with organisms such as Enterococcus, Enterobacter, Klebsiella and Serratia species, and the bacteria could cause illness and warp test results. 


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