Roche Diabetes Care, Inc.
FDA Regulatory Profile
Roche Diabetes Care, Inc. has 29 FDA recalls, 2 inspections, 13 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-2174-2024 · Class II · May 13, 2024
- Latest inspection
- Jul 25, 2019 · VAI
- Latest 510(k)
- Nov 13, 2023
Newer recall under related name Foundation Medicine: Jun 10, 2026, Z-2951-2026.
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 29 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 13 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 2 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
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… | Mar 9, 2022 |
| Z-2353-2021 | Class II | Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001… | Jul 28, 2021 |
| Z-2352-2021 | Class II | Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001 | Jul 28, 2021 |
| Z-2354-2021 | Class II | Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001 | Jul 28, 2021 |
| Z-2351-2021 | Class II | Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001… | Jul 28, 2021 |
| Z-0997-2020 | Class II | Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog… | Dec 11, 2019 |
| Z-0999-2020 | Class II | ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number… | Dec 11, 2019 |
| Z-0998-2020 | Class II | Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog… | Dec 11, 2019 |
| Z-0752-2020 | Class II | Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX… | Sep 30, 2019 |
| Z-0750-2020 | Class II | Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US… | Sep 30, 2019 |
| Z-0748-2020 | Class II | Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL… | Sep 30, 2019 |
| Z-0749-2020 | Class II | Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US… | Sep 30, 2019 |
| Z-0751-2020 | Class II | Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US… | Sep 30, 2019 |
| Z-0747-2020 | Class II | Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL… | Sep 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… | May 7, 2018 |
| Z-2186-2018 | Class II | Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product… | 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… | Jun 12, 2017 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232509 | Accu-Chek Safe-T-Pro Uno Lancing Device | Nov 13, 2023 |
| K232488 | Accu-Chek Safe-T-Pro Plus Lancing Device | Nov 13, 2023 |
| K213134 | Accu-Chek Solo micropump system with interoperable technology | Aug 10, 2023 |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Aug 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 | Apr 29, 2022 |
| K220364 | Accu-Chek Safe-T-Pro Uno Lancing Device | Apr 5, 2022 |
| K214022 | Accu-Chek Softclix Blood Lancing System | Feb 17, 2022 |
| K181131 | Accu-Chek Guide Me Blood Glucose Monitoring System | Dec 13, 2018 |
| K160944 | ACCU-CHEK Guide Blood Glucose Monitoring System | Aug 31, 2016 |
| K150910 | ACCU-CHEK Connect Diabetes Management App | Jun 3, 2015 |
| K122686 | ACCU-CHEK ULTRAFLEX INFUSION SET | Nov 16, 2012 |