Recall Z-3201-2018 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Medtronic Inc.
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'
| Date | May 16, 2018 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 2 |
| Distribution | International Distribution to Slovakia only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.