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    ROCHE DIABETES CARE, INC.

    FDA registration
    ROCHE DIABETES CARE, INC.·9 products·🇺🇸 United States

    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·November 23, 2016

    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NDC·September 14, 2016

    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.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NDC·March 14, 2017

    ACCUCHEK GUIDE METER

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·June 25, 2024

    ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code JQP·October 30, 2014

    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.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code JQP·March 9, 2022

    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.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NBW·September 30, 2019

    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.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NBW·September 30, 2019

    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.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NBW·September 30, 2019

    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.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code LFR·May 7, 2018

    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.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NBW·June 12, 2017

    Accu-Chek Connect Diabetes Management App

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NDC·May 3, 2019

    Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001

    FDA Recall
    Open, Classified ·Roche Diabetes Care, Inc.·Product code LZG·July 28, 2021

    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

    FDA Recall
    Open, Classified ·Roche Diabetes Care, Inc.·Product code NBW·May 13, 2024

    AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code LZG·April 22, 2015

    Accu-Chek Connect Diabetes Management App

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NDC·December 20, 2016

    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.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code LFR·May 7, 2018

    Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NBW·December 11, 2019

    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.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NBW·September 30, 2019