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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 09, 2023
Date Posted January 16, 2024
Recall Status1 Completed
Recall Number Z-0734-2024
Recall Event ID 93393
510(K)Number K213996  
Product Classification Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems - Product Code QLG
Product FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Code Information UDI-DI: 00357599816001, Software v.3.4.0 and below
Recalling Firm/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda CA 94502-7000
For Additional Information Contact Lindsy Delco
510-749-5000
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = QLG and Original Applicant = Abbott Diabetes Care Inc.
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