The Recall Desk
HighFDA (Devices)·Z-0747-2020·Announced 2020-01-08

Roche Recalls Accu-Chek Guide Blood Glucose Monitoring System Due to Power Issues

Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 318,678 units distributed in the US and 35 other countries.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device used for critical health monitoring (diabetes) where a power issue could lead to inaccurate readings or lack of monitoring, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Roche Diabetes Care, Inc. is recalling the Accu-Chek Guide Blood Glucose Monitoring System, Model Number 07400870001, due to potential power issues. The affected product 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 for people with diabetes.

The recall involves 318,678 units. The distribution pattern includes US Nationwide distribution and the following countries: 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, and ZA. The affected serial numbers are all below XXX11000001, where XXX is the first 3 digits of the serial number.

The source text does not specify the exact corrective actions consumers should take or the specific symptoms of the power issues. Users should refer to the official FDA recall notice or contact the manufacturer for specific instructions on how to proceed.

The recalled product

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
Manufacturer
Roche Diabetes Care, Inc.
Category
Medical Device — Blood Glucose Monitoring
Hazard
Affected units
318,678

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Roche Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Roche Diabetes Care, Inc.

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Same hazard · power issue

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