Abbott Diabetes Care, Inc.
Abbott Diabetes Care, Inc. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2024, with 18 FDA device recalls on record.
Top product codes for Abbott Diabetes Care, Inc.
FDA recalls by Abbott Diabetes Care, Inc.
10 most recent of 18- Z-1021-2026 — 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.
- Z-1022-2026 — 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.
- Z-1020-2026 — 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.
- Z-1023-2026 — 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.
- Z-2692-2024 — FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
- Z-2414-2023 — FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
- Z-1275-2023 — FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
- Z-1273-2023 — FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
- Z-1274-2023 — FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
- Z-0734-2024 — FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Abbott Diabetes Care, Inc.
- K233537 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- K223435 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- K222447 — FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
- K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 System
- K212132 — FreeStyle Libre 3 Continuous Glucose Monitoring System
- K213996 — FreeStyle Libre 3 Continuous Glucose Monitoring System
- K210943 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
- K211102 — FreeStyle Libre 2 Flash Glucose Monitoring System
- K201761 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
- K193371 — FreeStyle Libre 2 Flash Glucose Monitoring System
- K171941 — FreeStyle Precision Neo Blood Glucose Test Strips
- K153330 — FreeStyle Precision Neo H Blood Glucose Monitoring System
- K142928 — FreeStyle Precision Neo Blood Glucose Monitoring System
- K140371 — FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)
- K132511 — FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
- K120568 — FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
- K092638 — FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23
- K092602 — FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System
- K083223 — RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
- K083225 — FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
- K081975 — RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)
- K080960 — PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS
- K071788 — AVIATOR INSULIN PUMP
- K070984 — THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
- K070850 — FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
- K062770 — COPILOT HEALTH MANAGEMENT SYSTEM
- K060768 — PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
- K051839 — FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
- K051041 — INSULIN PUMP
- K051802 — FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
- K050500 — FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM
- K031260 — FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005
- K020866 — FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
- K012014 — MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
- K000582 — FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
- K994433 — CONNECT DATA MANAGEMENT SYSTEM
- K992684 — FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.