The FDA sent a warning letter to Abbott about the accuracy of Freestyle Libre CGMs:
" The warning letter, dated Jan. 23 and posted to the FDA’s website on Tuesday, concerns performance specifications and testing for the glucose sensors’ accuracy. An Abbott spokesperson wrote in an email that the company is implementing corrective actions and providing ongoing updates to the FDA."
What the FDA found:
"Inspectors found that Abbott did not transfer specific glucose sensor accuracy requirements to third-party manufacturers, and did not ensure ongoing monitoring of products that are in process or finished. Abbott responded to these concerns in November and December, but the FDA determined that the firm’s responses were inadequate.
The FDA said its inspection showed that Abbott released finished FreeStyle Libre CGMs without first testing them for accuracy after they had been fully assembled, sterilized and programmed.
“Reliance on upstream, component-level testing performed prior to critical manufacturing steps does not ensure that finished, sterilized, and packaged devices meet accuracy performance requirements at the time of release,” the warning letter stated."
The whole article is worth reading. I don’t think anyone here is surprised.