Blood Glucose Monitoring System — Class II medical device recall Z-0747-2020
Terminated recall by Roche Diabetes Care, Inc., reported 2020-01-08, distributed nationwide. Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
| Recall number | Z-0747-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diabetes Care, Inc., Indianapolis, IN, United States |
| Recall initiated | 2019-09-30 |
| Classified | 2019-12-30 |
| Reported by FDA | 2020-01-08 |
| Terminated | 2020-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 318,678 |
| UPC / GTIN / UDI-DI | 00365702702035 |
| Model numbers | 07400870001 |
Product
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.
Reason for recall
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0747-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.