Z-0734-2024Class II

FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating...

Name: Z-0734-2024 FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating...
Creator: Abbott Diabetes Care, Inc.
Published: 2023-02-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-02-09 / Completed / root cause: software

FDA source

Abbott Diabetes Care, Inc. began a recall of FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System on 2023-02-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-0734-2024
Classification: Class II
Status: Completed
Initiated: 2023-02-09
Posted: 2024-01-16
Recalling firm: Abbott Medical
Product: FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Product code: QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
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.
Root cause tag: software
FDA 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 2/27/23, another Important Message/Communication was sent to customers informing them that updated software version 3.4.2 was available to fix the connection issue. Questions can be directed to Customer Care team at 1-855-632-8658. The team is available 7 days a week from 8 AM to 8 PM Eastern Time, excluding holidays.
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 00357599816001, Software v.3.4.0 and below

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0734-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0734-2024	Class II	Completed	Voluntary: Firm initiated	2024-01-24	2024-01-16

Product code QLG

K213996Class IIFreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc. / cleared 2022-05-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)