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Roche Diabetes Care GmbH

Germany Last updated 25 Oct 2026

Devices
12
Registries
EUDAMEDFDA 510(k)FDA
FDA recalls
295 ongoing

Catalogue12

FDA recalls29

Device pages show only the recalls that name the device or its 510(k)/PMA.

FDA recall records list 29 recalls initiated by Roche Diabetes Care GmbH, the earliest on 2014-10-30 and the most recent on 2024-05-13. By recorded status: 5 ongoing and 24 terminated. The reasons filed fall into these groups: software or firmware, electrical or power, 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.

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.

Showing the 10 most recent of 29 recalls.

  • 2024

    • 13 May 2024 Z-2174-2024 Class II Ongoing The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.

  • 2022

    • 9 Mar 2022 Z-1008-2022 Class II Terminated Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.

  • 2021

    • 28 Jul 2021 Z-2351-2021 Class II Ongoing Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
    • 28 Jul 2021 Z-2352-2021 Class II Ongoing Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
    • 28 Jul 2021 Z-2353-2021 Class II Ongoing Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
    • 28 Jul 2021 Z-2354-2021 Class II Ongoing Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

  • 2019

    • 11 Dec 2019 Z-0997-2020 Class II Terminated Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
    • 11 Dec 2019 Z-0998-2020 Class II Terminated Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
    • 11 Dec 2019 Z-0999-2020 Class II Terminated Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
    • 30 Sep 2019 Z-0747-2020 Class II Terminated Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
Show the 25 most recent of 29 recalls

  • 2019

    • 30 Sep 2019 Z-0748-2020 Class II Terminated Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
    • 30 Sep 2019 Z-0749-2020 Class II Terminated Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
    • 30 Sep 2019 Z-0750-2020 Class II Terminated Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
    • 30 Sep 2019 Z-0751-2020 Class II Terminated Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
    • 30 Sep 2019 Z-0752-2020 Class II Terminated Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
    • 3 May 2019 Z-2753-2019 Class II Terminated Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.

  • 2018

    • 7 May 2018 Z-2185-2018 Class II Terminated The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result.
    • 7 May 2018 Z-2186-2018 Class II Terminated The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.
    • 7 May 2018 Z-2187-2018 Class II Terminated The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.

  • 2017

    • 12 Jun 2017 Z-2765-2019 Class II Terminated Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
    • 12 Jun 2017 Z-2766-2019 Class II Terminated Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
    • 8 Jun 2017 Z-0197-2018 Class II Terminated Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. This same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed).
    • 8 Jun 2017 Z-0625-2018 Class II Terminated Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.
    • 14 Mar 2017 Z-1899-2017 Class II Terminated A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.

  • 2016

    • 20 Dec 2016 Z-1099-2017 Class II Terminated iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple meters with the Accu-Chek Connect app can under rare circumstances cause the bolus advisor to fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement (10 15 minutes). Depending on the individual metabolic situation potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Both software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect and should not be used to manually calculate a bolus.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Roche Diabetes Care, Inc. Indianapolis, IN · US FEI 3011393376

What Roche Diabetes Care GmbH makes

Roche Diabetes Care GmbH manufactures blood glucose monitoring systems, including handheld meters, continuous glucose monitoring devices, and insulin pumps with interoperable technology. Their portfolio includes systems for self-monitoring of blood glucose, such as the Accu-Chek Mobile and Accu-Chek Guide Solo, as well as integrated solutions combining meters with insulin delivery devices like the Accu-Chek Solo micropump system.

The company’s devices are classified as Class II and Class IIb medical devices, with some listed under IVD Annex II List B. These products are registered in the EU via eudamed and in the US through FDA 510(k) clearance. The manufacturer is based in Germany.

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

Frequently asked questions

How many devices does Roche Diabetes Care GmbH have in the registry?

The registry currently lists 12 devices for Roche Diabetes Care GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list Roche Diabetes Care GmbH's devices?

Among its 12 most recently registered devices, Roche Diabetes Care GmbH has devices listed in EUDAMED (10 devices) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Roche Diabetes Care GmbH's devices fall under?

Among its 12 most recently registered devices, the classes recorded for Roche Diabetes Care GmbH's devices are Class IIb, Class II and IVD Annex II List B. Each device page shows its own class and authorisation.

Are there FDA recall records for Roche Diabetes Care GmbH?

FDA recall records list 29 recalls initiated by Roche Diabetes Care GmbH, the most recent initiated on 2024-05-13. 5 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Roche Diabetes Care GmbH in the registry?

The most recently registered devices listed for Roche Diabetes Care GmbH include Accu-Chek Mobile, Accu-Chek Guide Solo diabetes manager blood glucose monitoring system, Accu-Chek Solo micropump system with interoperable technology and Accu-Chek Solo.

Which FDA establishments are linked to Roche Diabetes Care GmbH?

1 FDA establishment is linked to Roche Diabetes Care GmbH in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.

Information

Address
116, Sandhofer Strasse, Mannheim, Germany
Website
accu-chek.com
PRRC contact
Kai Küllmer
EUDAMED SRN
DE-MF-000006276
FDA FEI number
3011806823
DUNS number
313212471