Recall Z-0734-2024 ยท QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Abbott Diabetes Care, Inc.
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
| Date | Jan 16, 2024 (initiated Feb 9, 2023) |
| Status | Completed |
| Reason | If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required. |
| Root cause | Software design |
| Action | On 2/9/23, an Important Message/Communication was sent to customers informing them of the following: If you experience extended periods of signal loss, either of the following actions should allow reconnection: 1) Turn your smartphone's Bluetooth OFF and then ON 2) Turn your smartphone OFF and then ON To be notified if extended periods of signal loss occur: 1) Open your FreeStyle Libre 3 app, navigate to Alarms, and configure your signal loss alarm to be ON with "Override Do Not Disturb" enabled. 2) Please refer to www.FreeStyleAndroid.com for more information on how to configure alarms. On |
| Quantity | 45,173 |
| Distribution | US Nationwide distribution in the states of NY, CA, NJ, UT, PA, MS, OH, TX, MN, FL, LA, NE, MI, VA, NC, MA, IN, SC, IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System Abbott Diabetes Care, Inc., May 26, 2022 |