# FDA recall Z-0752-2020

> **Roche Diabetes Care, Inc.** · Class II · device recall initiated 2019-09-30.

## Product

Blood Glucose Monitoring System, Model Number 08313202001  ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - 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.

## Distribution

US Nationwide distribution and countries of AR, AT, AU, BE, BR, CA, CH, CL, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LT, LU, MM, MY, NL, NO, PH, PK, PT, SE, SG, TH, TW, ZA.

## Key facts

- **Recall number:** Z-0752-2020
- **Recalling firm:** Roche Diabetes Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-30
- **Report date:** 2020-01-08
- **Termination date:** 2020-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0752-2020

## Citation

> AI Analytics. FDA recall Z-0752-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0752-2020. Source: US FDA. Licensed CC0.

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