—#166154

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.

FDA product code: QBJ — Integrated Continuous Glucose Monitoring System, Factory Calibrated
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: Lot# MD04M051P S/N# BG1245623B and S/N# BG1245624B

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc.
Address: 18000 Devonshire St, Northridge, California 91325-1219

Distribution

Distribution pattern: International Distribution to Slovakia only.

Timeline

Recall initiated: 2018-05-16
Terminated: 2020-06-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166154. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.