Roche Diabetes Care, Inc.
Roche Diabetes Care, Inc. holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2023, with 29 FDA device recalls on record.
Top product codes for Roche Diabetes Care, Inc.
FDA recalls by Roche Diabetes Care, Inc.
10 most recent of 29- Z-2174-2024 — 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
- Z-1008-2022 — 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.
- Z-2353-2021 — Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
- Z-2351-2021 — Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
- Z-2354-2021 — Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
- Z-2352-2021 — Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
- Z-0997-2020 — Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
- Z-0998-2020 — Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
- Z-0999-2020 — ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
- Z-0751-2020 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Roche Diabetes Care, Inc.
- K232488 — Accu-Chek Safe-T-Pro Plus Lancing Device
- K232509 — Accu-Chek Safe-T-Pro Uno Lancing Device
- K220849 — Accu-Chek Safe-T-Pro Plus Lancing Device
- K203711 — IWL2020 Blood Glucose Monitoring System
- K220608 — Accu-Chek FastClix Blood Lancing System
- K220364 — Accu-Chek Safe-T-Pro Uno Lancing Device
- K214022 — Accu-Chek Softclix Blood Lancing System
- K160944 — ACCU-CHEK Guide Blood Glucose Monitoring System
- K150910 — ACCU-CHEK Connect Diabetes Management App
Data sourced from openFDA. This site is unofficial and independent of the FDA.