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Abbott Diabetes Care Ltd

United Kingdom (ex Northern Ireland) GB-MF-000029309 Last updated 30 May 2026 Part of Abbott Diabetes Care Inc

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Devices
86
Registries
EUDAMED
FDA recalls
579 ongoing

Catalogue86

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FDA recalls57

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Abbott Diabetes Care Ltd has initiated 57 recall records between August 30, 2005, and November 24, 2025, with statuses including completed, open, classified, and terminated. The recalls involve issues such as detaching button covers, incorrect unit settings (mmol/L instead of mg/dL), potential product diversion, software connectivity failures, moisture ingress due to cracked housing, inaccurate readings from voltage or strip malfunctions, misinterpreted software data, and unapproved disinfection instructions for multi-patient use. Some records also address erroneous glucose readings, delayed alarms, and miscalculated insulin doses due to sensor or software discrepancies.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 57 recalls.

  • 2025

    • 24 Nov 2025 Z-1020-2026 Class I Ongoing Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
    • 24 Nov 2025 Z-1021-2026 Class I Ongoing Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
    • 24 Nov 2025 Z-1022-2026 Class I Ongoing Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
    • 24 Nov 2025 Z-1023-2026 Class I Ongoing Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

  • 2024

    • 24 Jul 2024 Z-2692-2024 Class I Ongoing 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 hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.

  • 2023

    • 12 Jul 2023 Z-2414-2023 Class II Ongoing 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 result in no or delayed glucose results
    • 13 Feb 2023 Z-1273-2023 Class I Ongoing 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 instructions on reader safe storage, charging, use.
    • 13 Feb 2023 Z-1274-2023 Class I Ongoing 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 instructions on reader safe storage, charging, use.
    • 13 Feb 2023 Z-1275-2023 Class I Ongoing 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 instructions on reader safe storage, charging, use.
    • 9 Feb 2023 Z-0734-2024 Class II Completed 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 glucose (for low glucose) when required.
Show the 25 most recent of 57 recalls

  • 2019

    • 14 Nov 2019 Z-1556-2020 Class II Terminated 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 of an existing infection.
    • 14 Nov 2019 Z-1557-2020 Class II Terminated 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 of an existing infection.
    • 14 Nov 2019 Z-1558-2020 Class II Terminated 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 of an existing infection.

  • 2014

    • 19 Feb 2014 Z-1211-2014 Class I Terminated 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.
    • 19 Feb 2014 Z-1212-2014 Class I Terminated 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.

  • 2013

    • 18 Nov 2013 Z-0485-2014 Class I Terminated 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.
    • 18 Nov 2013 Z-0486-2014 Class I Terminated 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.
    • 15 Apr 2013 Z-1245-2013 Class I Terminated AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.

  • 2010

    • 22 Dec 2010 Z-0994-2011 Unclassified (pre-2012) Terminated 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.
    • 22 Dec 2010 Z-0995-2011 Unclassified (pre-2012) Terminated 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.
    • 22 Dec 2010 Z-0996-2011 Unclassified (pre-2012) Terminated 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.
    • 22 Dec 2010 Z-0997-2011 Unclassified (pre-2012) Terminated 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.
    • 22 Dec 2010 Z-0998-2011 Unclassified (pre-2012) Terminated 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.
    • 22 Dec 2010 Z-0999-2011 Unclassified (pre-2012) Terminated 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.
    • 22 Dec 2010 Z-1000-2011 Unclassified (pre-2012) Terminated 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.

What Abbott Diabetes Care Ltd makes

The company manufactures continuous glucose monitoring (CGM) systems and flash glucose monitoring devices, including standalone sensors and integrated systems paired with companion apps. These products provide real-time or intermittent glucose readings for individuals managing diabetes, with some models offering automated alerts for high or low blood sugar levels. Additional offerings include standalone glucose sensors designed for portable, non-invasive monitoring.

The portfolio is classified under Class IIb medical devices and is registered in the EU through the eudamed database. The company is based in the United Kingdom.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Abbott Diabetes Care Ltd manufacture?

Abbott Diabetes Care Ltd specialises in glucose monitoring solutions for diabetes management. Their portfolio includes continuous glucose monitoring (CGM) systems, such as the FreeStyle Libre series, which provide real-time or intermittent glucose readings. They also produce flash glucose monitoring devices, standalone glucose sensors, and companion apps like the FreeStyle Libre 3 app. These products are designed to offer users continuous or on-demand glucose tracking, often with automated alerts for high or low blood sugar levels.

Where is Abbott Diabetes Care Ltd based?

Abbott Diabetes Care Ltd is headquartered in the United Kingdom. The company’s UK base supports its global operations in developing and distributing glucose monitoring technologies for diabetes management.

Which regulatory registries list Abbott Diabetes Care Ltd’s devices?

Abbott Diabetes Care Ltd’s medical devices are listed in the eudamed database, which is the official EU registry for medical devices. This registration ensures transparency and compliance with EU medical device regulations for their Class IIb products.

How are Abbott Diabetes Care Ltd’s devices classified under medical device regulations?

Abbott Diabetes Care Ltd’s glucose monitoring devices fall under Class IIb classification. This classification is determined based on factors like the device’s risk level, intended use, and potential impact on patient safety. Class IIb devices require stricter regulatory oversight than lower-risk categories but are not considered high-risk like Class III devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United Kingdom (ex Northern Ireland)
Address
Range Road, Witney, United Kingdom (ex Northern Ireland)
Website
abbott.com
Phone
+1(855)632-8658
PRRC contact
Connor Barry
EUDAMED SRN
GB-MF-000029309
DUNS number
763477098