The Recall Desk
HighFDA (Devices)·Z-3201-2018·Announced 2018-09-26

Medtronic Recalls Contour Plus Link 2.4 Meters with Incorrect Units

Medtronic is recalling two Contour Plus Link 2.4 meters distributed in Slovakia that display glucose in mg/dL instead of mmol/L.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could lead to incorrect health decisions (misinterpretation of glucose levels), fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Inc. is recalling two units of the Contour Plus Link 2.4 wireless blood glucose monitoring system (Product Catalog Number: MMT-1151SK). The recall involves meters with serial numbers BG1245623B and BG1245624B from lot MD04M051P. These specific meters were incorrectly configured to display glucose measurements in mg/dL rather than the standard mmol/L unit used in the distribution region.

The affected products were distributed internationally to Slovakia only. The incorrect unit of measure may lead to misinterpretation of blood glucose results by users in regions where mmol/L is the standard. The recall is classified as Class II by the FDA.

Consumers who possess these specific serial numbers should stop using the meters and contact Medtronic for instructions on how to proceed. The recall is limited to the two specific units identified in the source text.

The recalled product

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 moni
Manufacturer
Medtronic Inc.
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot# MD04M051P S/N# BG1245623B and S/N# BG1245624B

Distribution

Distribution scope not specified by the agency.