The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0751-2020·Announced 2020-01-08

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

Roche Diabetes Care is recalling 355,400 Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall covers units distributed in the US and 33 other countries.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is described as a potential power issue, which fits the criteria for a moderate severity recall involving a risk of harm where injury has not yet been reported or a minor defect.

Plain-English summary

Roche Diabetes Care, Inc. is recalling 355,400 units of the Accu-Chek Guide Blood Glucose Monitoring System, Model Number 08453063001. The recall is due to potential power issues with the device. 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 includes devices with serial numbers below XXX11000001, where XXX represents the first three digits of the serial number. The Device Identifier is 00365702728103. These units were distributed nationwide in the United States and in 33 other countries, including Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, and the United Kingdom.

Consumers should stop using the affected devices and contact Roche Diabetes Care for instructions on how to return the product or obtain a replacement. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
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…
Manufacturer
Roche Diabetes Care, Inc.
Category
Medical Device — Blood Glucose Monitor
Hazard
Affected units
355,400

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 →

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