Reported Jan 24, 2024 · Completed
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Abbott Diabetes Care, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Diabetes Care, Inc. · 1360 S Loop Rd · Alameda, CA · 94502-7000
Is this the product you have?
FreeStyle Libre 3 Apppart of Continuous Glucose Monitoring Systemwhen used on the Android 13 Operating System
- Lot codes and dates
- UDI-DI
00357599816001Software v.3.4.0 and below
- UDI-DI
- Amount recalled
- 45,173
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Abbott Diabetes Care, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.