- #CONTOUR NEXT LINK 2.4 METER FULL#
- #CONTOUR NEXT LINK 2.4 METER SOFTWARE#
- #CONTOUR NEXT LINK 2.4 METER CODE#
Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. International Distribution to Slovakia only.ġ A record in this database is created when a firm initiates a correction or removal action. If you have any questions, contact the Program Manager, Field Corrective Action at 81. Medtronic will provide a free replacement.
Return your recalled CONTOUR"PLUS LINK 2.4 meter to Medtronic by following the instructions provided by the Helpline representative. 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.ĭ. If the REF and LOT match this notice, stop using the CONTOUR"PLUS LINK 2.4 meter immediately.Ĭ.
#CONTOUR NEXT LINK 2.4 METER SOFTWARE#
software allows you to upload the data from your pump and glucose meter to a secure website and. Confirm if the Model (REF) of your meter is MMT-1151SK and the batch (LOT) number is MD04M051P.ī. Getting started I Using the CONTOUR NEXT LINK 2.4 meter. The customers were instructed to do the following:Ī. The letter described the product, problem and actions to be taken. 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. This meter contains the incorrect unit of measure mg/dL instead of mmol/L. laboratory method for blood glucose concentrations, specifically: 99.3 of results within ☑0 for blood glucose concentrations 5.55 mmol/L, and 98. Lot# MD04M051P S/N# BG1245623B and S/N# BG1245624BĬONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. CONTOUR ® NEXT LINK 2.4 meter meets ☑0 accuracy vs. CONTOUR NEXT LINK 2.
#CONTOUR NEXT LINK 2.4 METER FULL#
wireless blood glucose monitoring systemĬontour 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. Second-Chance ® Sampling lets you apply more blood to the same strip, within 30 seconds, if you didn’t get enough the first time, helping to prevent wasted strips.
Evaluation of the CONTOUR®NEXT LINK 2.4 Blood Glucose Monitoring System. Wirelessly sends results proven to be highly accurate to the MiniMed. Integrated Continuous Glucose Monitoring system, factory calibrated - Product Code QBJĬontour Plus Link 2.4, Product Catalog Number: MMT-1151SK. The only FDA-approved meter as part of the MiniMed TM 630G1 and MiniMed 670G2 systems. Class 2 Device Recall Contour Plus Link 2.4
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