Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems
Roche Diabetes Care is recalling specific Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues.
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 where injury or harm has not yet been reported.
Plain-English summary
Roche Diabetes Care, Inc. is recalling the Accu-Chek Guide Blood Glucose Monitoring System, Model Number 08453071001. The recall involves 3,996 units that were distributed nationwide in the United States and in various international markets.
The recall was initiated due to potential power issues with the device. The Accu-Chek Guide 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 for people with diabetes.
Consumers should check their device model number and serial number to determine if it is affected. The recall includes devices with serial numbers below XXX11000001, where XXX represents the first three digits of the serial number. Users should stop using affected units and contact Roche Diabetes Care for instructions on replacement or refund.
The recalled product
- Product
- 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
- Manufacturer
- Roche Diabetes Care, Inc.
- Hazard
- Affected units
- 3,996
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
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Same hazard · power issue
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