Recall Z-2692-2024 ยท QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Abbott Diabetes Care, Inc.
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
| Date | Aug 27, 2024 (initiated Jul 24, 2024) |
| Status | Open, Classified |
| Reason | Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual gluco |
| Root cause | Process design |
| Action | On 7/24/24, correction notices were distributed to customers, distributors, wholesalers. In addition, a news release was posted. FSL3 app users started receiving a message, with a clickable link to the notification, prior to the starting each new senor. Customers were asked to do the following: 1) To determine if your current sensor or any unused sensors you have are affected, please visit www.FreeStyleConfirm.com and select "CONFIRM SENSOR SERIAL NUMBER". 2) If you are wearing a Sensor, you can find the Serial number in the App or Reader. The Serial Number can also be found on the bottom |
| Quantity | 8,174 |
| Distribution | US distribution to states of: NJ, PA, OH, TX, VA, CA, NY, FL, WA, MS, MN, and WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System Abbott Diabetes Care, Inc., May 26, 2022 |