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Abbott Diabetes Care Ltd

Active in EUDAMED
Also registered as ABBOTT DIABETES CARE LIMITED

United Kingdomfrom SRN EUDAMED SRN GB-MF-000029309

Part of Abbott Diabetes Care Inc

Devices
184
Registrations
EUDAMED
FDA recalls
579 ongoing

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue184

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Company details

EUDAMED SRN
GB-MF-000029309
DUNS number
763477098
EU VAT number
GB537150752
EUDAMED status
Active
EUDAMED registered name
Abbott Diabetes Care Ltd
EUDAMED abbreviated name
ADC Ltd
Registered address
Range Road, OX29 0YL, Witney, United Kingdom (ex Northern Ireland)
Phone
+1(855)632-8658
PRRC contact
Connor Barry(public in EUDAMED)

FDA recalls57

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 57 recalls initiated by Abbott Diabetes Care Ltd, the earliest on 2005-08-30 and the most recent on 2025-11-24. By recorded status: 9 ongoing, 47 terminated and 1 with another status. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, electrical or power, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 3
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 5
  • 2024 1
  • 2025 4
  • 2026 0

44 initiated before 2017

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 Distribution: U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA,…
      Full distribution text U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WI, WV, and WY. O.U.S.: Andorra, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, New Zealand, Norway, Qatar, San Marino, Spain, Sweden, Switzerland, and United Kingdom.
      Submission number: K212132
    • 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 Distribution: U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA,…
      Full distribution text U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WI, WV, and WY. O.U.S.: Andorra, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, New Zealand, Norway, Qatar, San Marino, Spain, Sweden, Switzerland, and United Kingdom.
      Submission number: K233537
    • 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 Distribution: U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA,…
      Full distribution text U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WI, WV, and WY. O.U.S.: Andorra, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, New Zealand, Norway, Qatar, San Marino, Spain, Sweden, Switzerland, and United Kingdom.
      Submission number: K233537
    • 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 Distribution: U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA,…
      Full distribution text U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WI, WV, and WY. O.U.S.: Andorra, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, New Zealand, Norway, Qatar, San Marino, Spain, Sweden, Switzerland, and United Kingdom.
      Submission number: K212132

  • 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. Distribution: US distribution to states of: NJ, PA, OH, TX, VA, CA, NY, FL, WA, MS, MN, and WY Submission number: K212132

  • 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 Distribution: US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA. Submission number: K193371
    • 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. Distribution: U.S. Nationwide. Submission number: P160030
    • 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. Distribution: U.S. Nationwide. Submission number: P160030S017
    • 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. Distribution: U.S. Nationwide. Submission number: K193371
    • 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. Distribution: US Nationwide distribution in the states of NY, CA, NJ, UT, PA, MS, OH, TX, MN, FL, LA, NE, MI, VA, NC, MA, IN, SC, IA. Submission number: K213996
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. Distribution: U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH,…
      Full distribution text U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH, MN, NM, VA, IN
      Submission number: K040814
    • 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. Distribution: U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH,…
      Full distribution text U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH, MN, NM, VA, IN
      Submission number: K081975
    • 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. Distribution: U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH,…
      Full distribution text U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH, MN, NM, VA, IN
      Submission numbers: K060768, K070984

  • 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. Distribution: Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden,…
      Full distribution text Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
      Submission number: K092638
    • 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. Distribution: Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden,…
      Full distribution text Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
      Submission number: K092638

  • 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. Distribution: Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark,…
      Full distribution text Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consumers/User**
      Submission number: K092602
    • 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. Distribution: Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark,…
      Full distribution text Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consumers/User**
      Submission number: K092602
    • 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. Distribution: Nationwide Distribution Submission number: K120568

  • 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. Distribution: Products were released for distribution in US and Puerto Rico. Submission number: K070984
    • 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. Distribution: Products were released for distribution in US and Puerto Rico. Submission number: K081975
    • 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. Distribution: Products were released for distribution in US and Puerto Rico. Submission number: K051213
    • 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. Distribution: Products were released for distribution in US and Puerto Rico. Submission number: K051213
    • 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. Distribution: Products were released for distribution in US and Puerto Rico. Submission number: K070984
    • 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. Distribution: Products were released for distribution in US and Puerto Rico. Submission number: K051213
    • 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. Distribution: Products were released for distribution in US and Puerto Rico. Submission number: K083223