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Panels › Clinical Chemistry › Product code QLG · Class 2

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Regulation 862.1355

0510(k)s in 12 months (9 all time)
4recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in QLG

Company510(k)sRecalls
Abbott Diabetes Care, Inc.78
Bigfoot Biomedical, Inc.21
Cardinal Health Inc.01
DateFirm and productCodeLinked 510(k)
Jan 14, 2026Abbott Diabetes Care, Inc.
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Open, Classified		 QLGK212132
Jan 14, 2026Abbott Diabetes Care, Inc.
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Open, Classified		 QLGK233537
Jan 14, 2026Abbott Diabetes Care, Inc.
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Open, Classified		 QLGK233537
Jan 14, 2026Abbott Diabetes Care, Inc.
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Open, Classified		 QLGK212132
Jun 20, 2025BIGFOOT BIOMEDICAL
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Conf
Open, Classified		 QLGK202145
Aug 27, 2024Abbott Diabetes Care, Inc.
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
Open, Classified		 QLGK212132
Jan 16, 2024Abbott Diabetes Care, Inc.
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Completed		 QLGK213996
Aug 17, 2023Abbott Diabetes Care, Inc.
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Open, Classified		 QLGK193371
Apr 6, 2023Abbott Diabetes Care, Inc.
FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
Open, Classified		 QLGK193371
Mar 16, 2021Cardinal Health Inc.
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Open, Classified		 QLGK193371

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