What is FDA product code QLG?

An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems.

Clinical Chemistry › Test SystemsIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Libre App

Name: Libre App
Brand: Libre App

Libre IOS App US

Registry build 21.09.26

1manufacturer

1catalogue number

7510(k) clearances naming this product code

8recalls on this code

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QLG
Manufacturer	City	Province	Registered as	Device types
Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6

Record

Regulatory record for Libre App
Listed by	Abbott Diabetes Care Limited, United Kingdom
FDA product code	QLG
Device type	Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Device class	Class 2
Regulation	21 CFR 862.1355
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K233537
Record published	2024-12-17
Record revised	2025-07-14 (version 2)

Specifications

Specifications
MRI safety	MR Conditional
Single use	Yes

Catalogue Numbers

Catalogue numbers for Libre App
Catalogue number	Size	Status
78746-01		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bigfoot Unity Diabetes Management System	Bigfoot Biomedical, Inc.	39
Bigfoot Unity	Bigfoot Biomedical, Inc.	15
FreeStyle Libre 2	Abbott Diabetes Care Limited	4
FreeStyle Libre 3	Abbott Diabetes Care Limited	2
FreeStyle Libre 3 App	Abbott Diabetes Care Limited	2
FreeStyle Libre 2 App	Abbott Diabetes Care Limited	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K223537	2023-02-21
K212132	2022-05-26
K213996	2022-05-26
K210943	2021-11-22
K211102	2021-08-11
K201761	2021-07-30
K193371	2020-06-12

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Libre App
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Abbott Diabetes Care Limited	510(k) number	2025-11-24	Class I	Process control	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results	1,663,241 sensors
Abbott Diabetes Care Limited	510(k) number	2025-11-24	Class I	Process control	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results	258,913 sensors

Recalls

4 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2025-11-24	Class I	Process control	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results	1,060,723 sensors
2025-11-24	Class I	Process control	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results	8,062 sensors
2024-07-24	Class I	Process design	Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inacc	8,174
2023-07-12	Class II	Software Design Change	If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn’t used for the full 14-day wear time, then the reader may display “Incompatible Sensor” message. If users don’t have the previous sensor, or Fr	1,722,645
2023-02-13	Class I	Device Design	Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it	1,534,532
2023-02-09	Class II	Software design	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 undetec	45,173

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.