Data / Medical devices / United States / Abbott Diabetes Care Inc.
Abbott Diabetes Care Inc.: FDA-registered device maker in Alameda, CA, United States, 26 510(k) clearances and 2 PMA approvals
Abbott Diabetes Care Inc. is registered with the FDA (registration 2954323) in Alameda, CA, United States. It lists 16 device types. The FDA files 26 510(k) clearances and 2 PMA approvals under its listings, the newest dated May 29, 2024. 23 recall events name it as the recalling firm (6 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2954323
- FEI number
- 3002803444
- Address
- 1360 South Loop RD., Alameda, CA, United States, 94502
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 26, 2007
- Registered through
- 2027
- Brand names listed
- ACE Control (LN 06U8210), ACE Control (LN 06U8610), ARCHITECT Insulin Controls (LN 08K4112), ARCHITECT STAT High Sensitivity Troponin-I Controls (LN 2R98-10), Abbott SF Single Use Lancing Device, Alere NT-proBNP for Alinity i Controls (LN 04S7911), Alinity c ASO Control I (LN 04S0912), Alinity c ASO Control II (LN 04S0913) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 29, 2024 | K233655 | Lingo Glucose System | SAF | Substantially Equivalent | Abbott | accessdata.fda.gov |
| April 23, 2024 | K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | QBJ | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| April 13, 2023 | K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | QBJ | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| March 3, 2023 | K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| October 3, 2022 | K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | QRL | Substantially Equivalent | Owen Mumford, Ltd. | accessdata.fda.gov |
| August 12, 2022 | K221126 | Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets | FMK | Substantially Equivalent | Owen Mumford, Ltd. | accessdata.fda.gov |
| July 15, 2022 | K221433 | Facet 28G Universal Lancet | QRK | Substantially Equivalent | Facet Technologies, LLC | accessdata.fda.gov |
| May 26, 2022 | K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System | QLG | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| May 26, 2022 | K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System | QLG | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| November 22, 2021 | K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | QLG | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| July 30, 2021 | K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | QLG | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| June 12, 2020 | K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | QLG | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| September 27, 2017 | K171941 | FreeStyle Precision Neo Blood Glucose Test Strips | NBW | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| September 30, 2015 | K142928 | FreeStyle Precision Neo Blood Glucose Monitoring System | NBW | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| September 17, 2015 | K152328 | FreeStyle InsuLinx Blood Glucose Monotioring System | LFR | Substantially Equivalent | Abott Laboratories | accessdata.fda.gov |
| June 5, 2015 | K150531 | FreeStyle Freedom Lite Blood Glucose Monitoring System | NBW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 5, 2015 | K150332 | FreeStyle Lite Blood Glucose Monitoring System | NBW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| December 24, 2013 | K132511 | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM | NBW | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| June 15, 2010 | K092638 | FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 | NBW | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| November 26, 2008 | K081975 | RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) | NBW | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| September 5, 2008 | K080960 | PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS | NBW | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| November 1, 2007 | K070984 | THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS | LFR | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| December 14, 2006 | K062770 | COPILOT HEALTH MANAGEMENT SYSTEM | NBW | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| April 21, 2006 | K060768 | PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS | JIN | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| May 27, 2005 | K051213 | PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS | NBW | Substantially Equivalent | Abbott Laboratories, Inc. | accessdata.fda.gov |
| April 15, 2004 | K040814 | MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM | NBW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 27, 2017 | P160030 | Freestyle Libre Flash Glucose Monitoring System | PZE | 54 | September 1, 2026 | accessdata.fda.gov |
| September 23, 2016 | P150021 | FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM | MDS | 59 | September 1, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 24, 2025 | 98049 | Class I | Ongoing | 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. | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results | accessdata.fda.gov |
| July 24, 2024 | 95047 | Class I | Ongoing | FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System | 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 inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hyp | accessdata.fda.gov |
| July 12, 2023 | 92708 | Class II | Ongoing | FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System | 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 FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could | accessdata.fda.gov |
| February 13, 2023 | 91756 | Class I | Ongoing | FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System | 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 will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instruction | accessdata.fda.gov |
| February 9, 2023 | 93393 | Class II | Completed | FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System | 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 g | accessdata.fda.gov |
| November 14, 2019 | 84866 | Class II | Terminated | Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144 | Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation | accessdata.fda.gov |
| February 19, 2014 | 67472 | Class I | Terminated | FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in yo | Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry. | accessdata.fda.gov |
| November 18, 2013 | 66886 | Class I | Terminated | FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Dia | Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health. | accessdata.fda.gov |
| April 15, 2013 | 64876 | Class I | Terminated | FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle Insu | AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading. | accessdata.fda.gov |
| December 22, 2010 | 57524 | Not yet classified | Terminated | Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. | accessdata.fda.gov |
| June 10, 2009 | 52427 | Not yet classified | Terminated | FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, manufactured by Abbott | Low results: Freestyle Lite Blood Glucose Test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with Freestyle Freedom Lite and Freestyle Lite Blood Glucose Meters. | accessdata.fda.gov |
| April 14, 2009 | 52635 | Not yet classified | Terminated | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB SYSTEM KIT(ORANGE)PACK NAV, Abbott Item Number 70684-01, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for cont | Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter. | accessdata.fda.gov |
| March 13, 2009 | 51399 | Not yet classified | Terminated | FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, for use with FreeStyle and FreeStyle Lite Test Strips respectively, 100 count, manufactured by Abbott | Product dispositioned for destruction was potentially diverted to end users. | accessdata.fda.gov |
| November 1, 2008 | 50202 | Not yet classified | Terminated | Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01. The product is manufactured by Benchmark Electronics, 3535 Technology Drive NW, Rochester, MN and distribut | The product has the Units of Measure set to mmol/L rather than mg/dL. The blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | accessdata.fda.gov |
| April 24, 2008 | 48090 | Not yet classified | Terminated | Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter | Flaws in strip voltage continuity may result in frequency of an Error 3 ("Er3") message display and unreadable strips. This issue has the potential for creating a delay in generating blood glucose results and to delay diabetes management, potentially leading to either hypo or hyperglycemia and their associated complications. | accessdata.fda.gov |
| August 2, 2007 | 39371 | Not yet classified | Terminated | Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and Improved meter, Precision Xceed meter, Optium Xceed meter, Optium meter, ReliOn Ultima meter, Rite Aid meter, Kroger meter, Omron | Damage could lead to no display. Meters manufactured after January 31, 2007 could exhibit meter display damage if dropped on a hard surface. These meters could exhibit unreadable lot number fields and date/time fields, in addition to complete blanking of the numerical reading portion of the display. | accessdata.fda.gov |
| March 5, 2007 | 37538 | Not yet classified | Terminated | Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit. | The front button covers may detach from the meter. | accessdata.fda.gov |
| December 18, 2006 | 37385 | Not yet classified | Terminated | Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); Serial Number(s): ALL | If the time and date are not set correctly on both the user's meter and computer, there is the potential for incorrect times and dates to be assigned to the results in the Precision Link Software. | accessdata.fda.gov |
| May 22, 2006 | 35486 | Not yet classified | Terminated | Abbott brand FreeStyle Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky. Alameda, CA 94502. Manufactured by: Flextronics International, Long Jing Industrial Estate, Long Jing Road, Xi Li Tow | The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure, and strip calibration code. | accessdata.fda.gov |
| February 17, 2006 | 34665 | Not yet classified | Terminated | FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control Solutions and Test Strips; Part Number: 70672-01; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, | The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result. | accessdata.fda.gov |
| August 30, 2005 | 33317 | Not yet classified | Terminated | FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging. | Downloadable software obtained from the firm's website displays user data (including but not limited to insulin levels and pump statistics data) in a matter that may be misinterpreted and result in mistreatment of therapy. | accessdata.fda.gov |
| June 7, 2005 | 33301 | Not yet classified | Terminated | FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | accessdata.fda.gov |
| November 8, 2002 | 25087 | Not yet classified | Terminated | Precision PCx Test Strips Part Number: 98757-12 | Use of glucose blood strips may provide false high results | accessdata.fda.gov |
Compare with other makers
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- All makers of Integrated Continuous Glucose Monitoring System, Factory Calibrated
Updated September 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.