Roche Diabetes Care, Inc.

FDA Regulatory Profile

Summary

Total Recalls
29
510(k) Clearances
13
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2174-2024Class IIAccu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood May 13, 2024
Z-1008-2022Class IIRocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web applicMarch 9, 2022
Z-2354-2021Class IIAccu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001July 28, 2021
Z-2352-2021Class IIAccu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001July 28, 2021
Z-2351-2021Class IIAccu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 069082July 28, 2021
Z-2353-2021Class IIAccu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 063375July 28, 2021
Z-0997-2020Class IIAccu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog NDecember 11, 2019
Z-0999-2020Class IIACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 064December 11, 2019
Z-0998-2020Class IIAccu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog NumDecember 11, 2019
Z-0751-2020Class IIBlood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US -September 30, 2019
Z-0752-2020Class IIBlood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - PSeptember 30, 2019
Z-0747-2020Class IIBlood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - ProducSeptember 30, 2019
Z-0749-2020Class IIBlood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - ProSeptember 30, 2019
Z-0750-2020Class IIBlood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US -September 30, 2019
Z-0748-2020Class IIBlood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - ProducSeptember 30, 2019
Z-2753-2019Class IIAccu-Chek Connect Diabetes Management AppMay 3, 2019
Z-2187-2018Class IIAccu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product May 7, 2018
Z-2186-2018Class IIAccu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product UMay 7, 2018
Z-2185-2018Class IIAccu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268May 7, 2018
Z-2765-2019Class IIAccu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring SysteJune 12, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K232488Accu-Chek Safe-T-Pro Plus Lancing DeviceNovember 13, 2023
K232509Accu-Chek Safe-T-Pro Uno Lancing DeviceNovember 13, 2023
K213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemAugust 10, 2023
K213134Accu-Chek Solo micropump system with interoperable technologyAugust 10, 2023
K220849Accu-Chek Safe-T-Pro Plus Lancing DeviceMay 19, 2022
K203711IWL2020 Blood Glucose Monitoring SystemMay 6, 2022
K220608Accu-Chek FastClix Blood Lancing SystemApril 29, 2022
K220364Accu-Chek Safe-T-Pro Uno Lancing DeviceApril 5, 2022
K214022Accu-Chek Softclix Blood Lancing SystemFebruary 17, 2022
K181131Accu-Chek Guide Me Blood Glucose Monitoring SystemDecember 13, 2018
K160944ACCU-CHEK Guide Blood Glucose Monitoring SystemAugust 31, 2016
K150910ACCU-CHEK Connect Diabetes Management AppJune 3, 2015
K122686ACCU-CHEK ULTRAFLEX INFUSION SETNovember 16, 2012