The warning letter urges users and providers to throw the entire test cartridges in the trash due to the increased risk of false results.
The company said that if a specific combination of factors comes together, there is a risk of thermal injury.
The family-owned business reinforces its commitment to quality and evolving regulatory requirements.
In part 3 of MD+DI’s interview with Jim O’Connell, he details the potential longevity for connected care in medtech, as well as the challenges it could face.
Trivia Tuesday: What medical device company became embroiled in a fight with FDA that ultimately led to disciplinary action against two agency employees and the unseating of two advisory panel members?
Here are the sessions that MD+DI editors are keeping their eyes on during MD&M South.
Bouw uw eigen nieuws-stroom
Klaar om het te proberen?
Start een 14-daagse proef, geen credit card nodig.