Z-3201-2018Class II

Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour...

Name: Z-3201-2018 Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour...
Creator: Medtronic Inc.
Published: 2018-05-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-05-16 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. began a recall of Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring... on 2018-05-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3201-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-16
Posted: 2018-09-19
Terminated: 2020-06-30
Recalling firm: Medtronic, Inc.
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.
Product code: QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Medtronic, sent an "URGENT MEDICAL DEVICE RECALL- CONTOUR"PLUS LINK 2.4 Meter (MMT-1151SK - Batch# MD04M051P) Incorrect Unit of Measure" letter to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: A. Confirm if the Model (REF) of your meter is MMT-1151SK and the batch (LOT) number is MD04M051P. B. If the REF and LOT match this notice, stop using the CONTOUR"PLUS LINK 2.4 meter immediately. C. Call your local Helpline and let the customer service team know you received a notice stating you may have a CONTOUR"PLUS LINK 2.4 meter with the incorrect unit of measure. D. Return your recalled CONTOUR"PLUS LINK 2.4 meter to Medtronic by following the instructions provided by the Helpline representative. Medtronic will provide a free replacement. If you have any questions, contact the Program Manager, Field Corrective Action at 818-576-4700.
Quantity in commerce: 2
Distribution: International Distribution to Slovakia only.
Product codes and lots: Lot# MD04M051P S/N# BG1245623B and S/N# BG1245624B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3201-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3201-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-19

Product code QBJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)