medical Class II Updated 2018-09-26

Medtronic Inc. recalls Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. w

Recalled Product

Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and control solution) is designed for self-testing by persons with diabetes and the monitoring of glucose concentrations for quantitative glucose measurement in fresh capillary full blood removed from the user's fingertips or palms. It is only for in vitro diagnostic use.


Hazard / Issue

CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of measure mg/dL instead of mmol/L.

Issued by

FDA

Distribution: International Distribution to Slovakia only.
Lot/Code Info: Lot# MD04M051P S/N# BG1245623B and S/N# BG1245624B
View official government recall

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