Abbott Diabetes Care, Inc.

FDA Regulatory Profile

Summary

Total Recalls
18 (13 Class I)
510(k) Clearances
39
Inspections
14
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1022-2026Class IFreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sNovember 24, 2025
Z-1020-2026Class IFreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is aNovember 24, 2025
Z-1021-2026Class IFreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sNovember 24, 2025
Z-1023-2026Class IFreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sNovember 24, 2025
Z-2692-2024Class IFreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose MoniJuly 24, 2024
Z-2414-2023Class IIFreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 SystemJuly 12, 2023
Z-1274-2023Class IFreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day February 13, 2023
Z-1273-2023Class IFreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash GFebruary 13, 2023
Z-1275-2023Class IFreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 FlashFebruary 13, 2023
Z-0734-2024Class IIFreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 OpeFebruary 9, 2023
Z-1557-2020Class IIOptium EZ Blood Glucose Monitoring System, UDI: 00093815710653November 14, 2019
Z-1556-2020Class IIPrecision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144November 14, 2019
Z-1558-2020Class IIFreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810November 14, 2019
Z-1212-2014Class IFreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense,February 19, 2014
Z-1211-2014Class IFreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperatuFebruary 19, 2014
Z-0486-2014Class IFreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count ProNovember 18, 2013
Z-0485-2014Class IFreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 November 18, 2013
Z-1245-2013Class IFreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only withApril 15, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K233861Libre Rio Continuous Glucose Monitoring SystemJune 7, 2024
K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SApril 23, 2024
K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SApril 13, 2023
K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring SMarch 3, 2023
K223537FreeStyle Libre 2 System, FreeStyle Libre 3 SystemFebruary 21, 2023
K213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemMay 26, 2022
K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemMay 26, 2022
K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)November 22, 2021
K211102FreeStyle Libre 2 Flash Glucose Monitoring SystemAugust 11, 2021
K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)July 30, 2021
K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemJune 12, 2020
K171941FreeStyle Precision Neo Blood Glucose Test StripsSeptember 27, 2017
K153330FreeStyle Precision Neo H Blood Glucose Monitoring SystemFebruary 19, 2016
K142928FreeStyle Precision Neo Blood Glucose Monitoring SystemSeptember 30, 2015
K140371FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)September 30, 2014
K132511FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEMDecember 24, 2013
K130094FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEMJune 27, 2013
K120568FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMMarch 29, 2012
K092638FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23June 15, 2010
K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring SMay 14, 2010