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Terminated

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 Recall Z-3201-2018 · Posted None

Recalling FirmMedtronic Inc.
Recall StatusTerminated
Product CodeQBJ
Date Initiated2018-05-16
Date Terminated2020-06-30
Product Quantity2

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

International Distribution to Slovakia only.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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