Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Blood Glucose Monitoring System Recalled by Roche Diabetes Care, Inc. Due to Potential power issues with the Accu-Chek¿ Guide Blood...

Date: September 30, 2019
Company: Roche Diabetes Care, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diabetes Care, Inc. directly.

Affected Products

Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL 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.

Quantity: 3,996

Why Was This Recalled?

Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Roche Diabetes Care, Inc.

Roche Diabetes Care, Inc. has 29 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report