Recall Z-3201-2018— Medtronic Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., initiated 2018-05-16, terminated 2020-06-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-16
- Terminated
- 2020-06-30
- Firm location
- Northridge, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.