Recall Z-0734-2024— Abbott Diabetes Care, Inc.
Class II · Completed
Class II FDA medical device recall by Abbott Diabetes Care, Inc., initiated 2023-02-09. It names one FDA 510(k) clearance: K213996. Product: FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System. 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..
- Recalling firm
- Abbott Diabetes Care, Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2023-02-09
- Firm location
- Alameda, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.