Reported Sep 2, 2015 · Terminated
Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the…
Medtronic MiniMed Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic MiniMed Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219
Is this the product you have?
- 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.
- Lot codes and dates
254 of 254 codes
GLU100968UGLU102603UGLU102604UGLU102606UGLU102611UGLU102633UGLU105144UGLU104941UGLU105216UGLU113873UKIT207482UKIT207495UKIT209292UKIT209308UKIT209282UKIT209297UKIT207481UKIT207491UKIT207494UKIT209284UKIT227732UKIT227735UKIT227740UKIT227746UKIT229227UKIT229224UKIT237462UKIT207486UKIT241304UKIT241308UKIT241292UKIT242887UKIT210467UKIT210465UKIT242885UKIT242888UKIT242890UKIT242893UKIT210485UKIT254775UKIT254779UKIT247924UKIT258441UKIT249491UKIT263472UKIT226461UKIT258451UKIT249497UKIT249498UKIT259531UKIT265811UKIT258445UKIT267592UKIT267602UKIT255788UKIT267584UKIT267573UKIT267597UKIT267576UKIT267599U
- Amount recalled
- 254 units
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.
This product could cause temporary or reversible health problems — stop using it.
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