UK’s MHRA Issues Alerts for Glucofacts Software, X-ray Systems

January 13, 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety alert based on a notice issued by Ascensia Diabetes Care Holdings.

Ascensia said its Glucofacts Deluxe software for the Contour Next/Plus One blood glucose meter may give inaccurate readings when users enter insulin and carbohydrate values in the Contour Diabetes app in conjunction with version 3.10.07 of the software.

Read the notice here: www.fdanews.com/01-05-17-Ascensia.pdf.