Roche Diabetes Care, Inc.
Indianapolis, IN, US
ROCHE DIABETES CARE, INC. appears in FDA device records in Indianapolis, IN. FDA records list 13 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 29 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Roche Diabetes Care, Inc. between 2012 and 2023. The busiest year on record is 2022, with 5. The most recent is 2023, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2022 | 5 |
| 2023 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232509 | Accu-Chek Safe-T-Pro Uno Lancing Device | FMK | Substantially Equivalent | |
| K232488 | Accu-Chek Safe-T-Pro Plus Lancing Device | FMK | Substantially Equivalent | |
| K213134 | Accu-Chek Solo micropump system with interoperable technology | QFG | Substantially Equivalent | |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | NBW | Substantially Equivalent | |
| K220849 | Accu-Chek Safe-T-Pro Plus Lancing Device | FMK | Substantially Equivalent | |
| K203711 | IWL2020 Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K220608 | Accu-Chek FastClix Blood Lancing System | QRL | Substantially Equivalent | |
| K220364 | Accu-Chek Safe-T-Pro Uno Lancing Device | FMK | Substantially Equivalent | |
| K214022 | Accu-Chek Softclix Blood Lancing System | QRL | Substantially Equivalent | |
| K181131 | Accu-Chek Guide Me Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K160944 | ACCU-CHEK Guide Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K150910 | ACCU-CHEK Connect Diabetes Management App | NDC | Substantially Equivalent | |
| K122686 | ACCU-CHEK ULTRAFLEX INFUSION SET | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011393376 | 3011393376 | ROCHE DIABETES CARE, INC. | 9115 Hague Road, Indianapolis, IN 46250 US | 2026 | |
| 3011806823 | 3011806823 | Roche Diabetes Care GmbH | Sandhofer Strasse 116, Mannheim Baden-Wurttemberg 68305 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MRZAccessories, Pump, Infusion
- QFGAlternate Controller Enabled Insulin Infusion Pump
- OZPAutomated Insulin Dosing Device System, Single Hormonal Control
- NDCCalculator, Drug Dose
- JQPCalculator/Data Processing Module, For Clinical Use
- NXOCalprotectin, Fecal
- LFRGlucose Dehydrogenase, Glucose
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- LZGPump, Infusion, Insulin
- FPASet, Administration, Intravascular
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- NBWSystem, Test, Blood Glucose, Over The Counter
Recall records
Showing 25 of 29| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2174-2024 | Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Number: 08453071001 | 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. | Class II | Open, Classified | |
| Z-1008-2022 | RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product. | Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software. | Class II | Terminated | |
| Z-2354-2021 | Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001 | 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. | Class II | Open, Classified | |
| Z-2353-2021 | Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001 | 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. | Class II | Open, Classified | |
| Z-2352-2021 | Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001 | 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. | Class II | Open, Classified | |
| Z-2351-2021 | Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001 | 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. | Class II | Open, Classified | |
| Z-0999-2020 | ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020 | 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 | Class II | Terminated | |
| Z-0998-2020 | Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001 | 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 | Class II | Terminated | |
| Z-0997-2020 | Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001 | 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 | Class II | Terminated | |
| Z-0752-2020 | Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. | Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. | Class II | Terminated | |
| Z-0751-2020 | Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. | Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. | Class II | Terminated | |
| Z-0750-2020 | Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. | Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. | Class II | Terminated | |
| Z-0749-2020 | Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. | Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. | Class II | Terminated | |
| Z-0748-2020 | Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. | Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. | Class II | Terminated | |
| Z-0747-2020 | Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. | Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. | Class II | Terminated | |
| Z-2753-2019 | Accu-Chek Connect Diabetes Management App | Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App. | Class II | Terminated | |
| Z-2187-2018 | Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples. | 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. | Class II | Terminated | |
| Z-2186-2018 | Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips. | 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. | Class II | Terminated | |
| Z-2185-2018 | Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. | 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. | Class II | Terminated | |
| Z-2766-2019 | Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Accu-Chek Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). c. The Accu-Chek Aviva Plus Test Strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. | Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on). | Class II | Terminated | |
| Z-2765-2019 | Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Accu-Chek Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). c. The Accu-Chek Aviva Plus Test Strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. | Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on). | Class II | Terminated | |
| Z-0625-2018 | Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017 | 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. | Class II | Terminated | |
| Z-0197-2018 | Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data | 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). | Class II | Terminated | |
| Z-1899-2017 | Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice. | A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery. | Class II | Terminated | |
| Z-1099-2017 | Accu-Chek Connect Diabetes Management App | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain