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.”

Advertisement

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. 

At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.

Advertisement

Next Up in Supply Chain

  • Aurora, Colo.-based UCHealth Vice President of Supply Chain Richard Bagley has retired after more than four years with the health…

  • The FDA has flagged eight medical device recalls, corrections and early alerts affecting convenience kits, vascular access devices, IV administration…

Advertisement

Comments are closed.