Glucose monitor components recalled

The Spanish Agency for Medicines and Health Products (Aemps) has reported the cessation of marketing and recall of the MD3658 sensor and MD1158 transmitter included in the A8 TouchCare System continuous glucose monitoring system due to glucose measurement problems. Specifically, Aemps has been aware of errors in glucose measurements reported by the Portuguese authorities, which have been detected during a usability study and which caused several incidents.

He A8 TouchCare system is used for insulin delivery and monitoring glucose levels. It is composed of a pump, a continuous glucose monitoring system (optional) and a personal diabetes manager. The measure taken by the Aemps does not apply to the pump or the personal diabetes manager. The manufacturer of the A8 TouchCare System continuous glucose monitoring system is Medtrum Technologies INC, headquartered in China. In Europe it is represented through the company Biochemical Systems International SPA, based in Milan, Italy.

Two components included in the A8 TouchCare System continuous glucose monitoring system are recalled due to measurement errors📊 https://t.co/8ejYOkRqQD

— FACUA (@FACUA) April 14, 2026

According to the information provided by the Aemps, The distribution of the products has been by Biochemical Systems Internationalwho has confirmed that it has been limited to a center in Tenerife. However, the Agency has indicated that it is not possible to rule out its distribution at other points.

If you own one of the affected products, the Aemps advises not to use them and inform this to the email pscontrol@aemps.es, providing the information of the company where it was acquired.