Data / Medical devices / United States / Roche Diabetes Care, Inc.

Roche Diabetes Care, Inc.: FDA-registered device maker in Indianapolis, IN, United States, 7 510(k) clearances and 1 PMA approval

Name: Roche Diabetes Care, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Roche Diabetes Care, Inc. is registered with the FDA (registration 3011393376) in Indianapolis, IN, United States. It lists 9 device types. The FDA files 7 510(k) clearances and 1 PMA approval under its listings, the newest dated May 6, 2022. 15 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3011393376
Address: 9115 Hague Road, Indianapolis, IN, United States, 46250
Owner or operator: Roche Diagnostics Operations Inc. (9039767)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: June 12, 2008
Registered through: 2027
Brand names listed: 579-2-RSA Dynamic Interface v1.1, 713-2-cobase 8100 v1.5, 770-1-CCM-AOB v1.1, A/C Inform II Base Unit Kit, ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX, ACCU-CHECK Guide Blood Glucose Monitoring System, ACCU-CHECK INFORM II US 50CT 72/CS F2, ACCU-CHEK AVIVA ASPAC STRIP 50CT and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Insulin Dosing Device System, Single Hormonal Control	OZP	3	Manufacturer, Specification developer	accessdata.fda.gov
Calculator, Drug Dose	NDC	2	Manufacturer	accessdata.fda.gov
Calculator/Data Processing Module, For Clinical Use	JQP	1	Manufacturer	accessdata.fda.gov
Glucose Dehydrogenase, Glucose	LFR	2	Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer	accessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use Only	QRL	2	Manufacturer for export	accessdata.fda.gov
Pump, Infusion, Insulin	LZG	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer	accessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	2	Manufacturer for export	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer	accessdata.fda.gov

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 6, 2022	K203711	IWL2020 Blood Glucose Monitoring System	NBW	Substantially Equivalent	Roche Diabetes Care, Inc.	accessdata.fda.gov
December 13, 2018	K181131	Accu-Chek Guide Me Blood Glucose Monitoring System	NBW	Substantially Equivalent	Roche Diabetes Care	accessdata.fda.gov
August 31, 2016	K160944	ACCU-CHEK Guide Blood Glucose Monitoring System	NBW	Substantially Equivalent	Roche Diabetes Care, Inc.	accessdata.fda.gov
April 29, 2014	K133862	ACCU-CHEK AVIVA PLUS SYSTEM	NBW	Substantially Equivalent	Roche Diagnostics Corporation	accessdata.fda.gov
August 9, 2013	K131029	ACCU-CHEK AVIVA PLUS TEST STRIP	NBW	Substantially Equivalent	Roche Diagnostics Operations, Inc.	accessdata.fda.gov
October 11, 2012	K121679	ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM	NBW	Substantially Equivalent	Roche Diagnostics	accessdata.fda.gov
January 6, 2012	K113137	GLUCOSE TEST SYSTEM	NBW	Substantially Equivalent	Roche Diagnostics	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 28, 2016	P160017	MiniMed 670G System	OZP	126	September 29, 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
May 13, 2024	94655	Class II	Ongoing	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	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	accessdata.fda.gov
March 9, 2022	89898	Class II	Terminated	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.	accessdata.fda.gov
July 28, 2021	88362	Class II	Ongoing	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.	accessdata.fda.gov
December 11, 2019	84518	Class II	Terminated	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	accessdata.fda.gov
September 30, 2019	84119	Class II	Terminated	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 capil	Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.	accessdata.fda.gov
May 3, 2019	83566	Class II	Terminated	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.	accessdata.fda.gov
May 7, 2018	80018	Class II	Terminated	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 Bl	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 glu	accessdata.fda.gov
June 12, 2017	83574	Class II	Terminated	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 draw	Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).	accessdata.fda.gov
June 8, 2017	79001	Class II	Terminated	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 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 car	accessdata.fda.gov
June 8, 2017	77635	Class II	Terminated	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 indica	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	accessdata.fda.gov
March 14, 2017	76870	Class II	Terminated	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 Pl	A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.	accessdata.fda.gov
December 20, 2016	76147	Class II	Terminated	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	accessdata.fda.gov
September 14, 2016	75241	Class II	Terminated	Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016	Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor feature, which could lead to an incorrect insulin bolus recommendation.	accessdata.fda.gov
April 22, 2015	71235	Class II	Terminated	AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.	Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error messages. If the user does not act upon the E6 and E10 error messages appropriately, insulin delivery will be stopped and if unnot	accessdata.fda.gov
October 30, 2014	70775	Class II	Terminated	ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.	Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough investigation of the situation revealed that this issue may occur if the user changes the screen orientation of the from portrait to landscape or vise versa while loo	accessdata.fda.gov

Compare with other makers

Updated September 29, 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.