Roche Diabetes Care, Inc.
FDA Regulatory Profile
Roche Diabetes Care, Inc. appears in FDA public data with 29 recalls, 13 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2174-2024, Class II) was initiated on May 13, 2024. Its most recent 510(k) clearance was granted on November 13, 2023.
Summary
- Total Recalls
- 29
- 510(k) Clearances
- 13
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2174-2024 | Class II | Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood | May 13, 2024 |
| Z-1008-2022 | Class II | RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web applic | March 9, 2022 |
| Z-2354-2021 | Class II | Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001 | July 28, 2021 |
| Z-2353-2021 | Class II | Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 063375 | July 28, 2021 |
| Z-2351-2021 | Class II | Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 069082 | July 28, 2021 |
| Z-2352-2021 | Class II | Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001 | July 28, 2021 |
| Z-0999-2020 | Class II | ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 064 | December 11, 2019 |
| Z-0997-2020 | Class II | Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog N | December 11, 2019 |
| Z-0998-2020 | Class II | Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Num | December 11, 2019 |
| Z-0748-2020 | Class II | Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Produc | September 30, 2019 |
| Z-0751-2020 | Class II | Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - | September 30, 2019 |
| Z-0752-2020 | Class II | Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - P | September 30, 2019 |
| Z-0747-2020 | Class II | Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Produc | September 30, 2019 |
| Z-0749-2020 | Class II | Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Pro | September 30, 2019 |
| Z-0750-2020 | Class II | Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - | September 30, 2019 |
| Z-2753-2019 | Class II | Accu-Chek Connect Diabetes Management App | May 3, 2019 |
| Z-2185-2018 | Class II | Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268 | May 7, 2018 |
| Z-2186-2018 | Class II | Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product U | May 7, 2018 |
| Z-2187-2018 | Class II | Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product | May 7, 2018 |
| Z-2766-2019 | Class II | Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring Sy | June 12, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232488 | Accu-Chek Safe-T-Pro Plus Lancing Device | November 13, 2023 |
| K232509 | Accu-Chek Safe-T-Pro Uno Lancing Device | November 13, 2023 |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | August 10, 2023 |
| K213134 | Accu-Chek Solo micropump system with interoperable technology | August 10, 2023 |
| K220849 | Accu-Chek Safe-T-Pro Plus Lancing Device | May 19, 2022 |
| K203711 | IWL2020 Blood Glucose Monitoring System | May 6, 2022 |
| K220608 | Accu-Chek FastClix Blood Lancing System | April 29, 2022 |
| K220364 | Accu-Chek Safe-T-Pro Uno Lancing Device | April 5, 2022 |
| K214022 | Accu-Chek Softclix Blood Lancing System | February 17, 2022 |
| K181131 | Accu-Chek Guide Me Blood Glucose Monitoring System | December 13, 2018 |
| K160944 | ACCU-CHEK Guide Blood Glucose Monitoring System | August 31, 2016 |
| K150910 | ACCU-CHEK Connect Diabetes Management App | June 3, 2015 |
| K122686 | ACCU-CHEK ULTRAFLEX INFUSION SET | November 16, 2012 |