Medtronic MiniMed Inc. recalls Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the…

Recall date

July 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2442-2015

FDA classification

Class II

Brand / firm

Medtronic MiniMed Inc.

Sold / distributed

Distributed in Finland.

Why it was recalled

Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in Predictive Alerts setting: the on-screen Finnish translation for LOW/HIGH is reversed as HIGH/LOW.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.