Roche Recalls Accu-Chek Guide Blood Glucose Meters Due to Power Issues
Roche Diabetes Care is recalling 21,094 Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall covers units distributed in the US and 34 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 (blood glucose) where power issues could lead to inaccurate readings or lack of monitoring, posing a risk of harm without reported injuries.
Plain-English summary
Roche Diabetes Care, Inc. is recalling 21,094 units of the Accu-Chek Guide Blood Glucose Monitoring System (Model Number 07400942001). The recall is due to potential power issues with the device. The affected units are identified by serial numbers below XXX11000001, where XXX represents the first three digits of the serial number.
The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes to quantitatively measure glucose in fresh capillary whole blood. The device is intended to be used by a single person and should not be shared. The recall covers units distributed in the United States and 34 other countries, including Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, and the United Kingdom.
Consumers with affected devices should stop using them 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 the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY 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
- Manufacturer
- Roche Diabetes Care, Inc.
- Affected units
- 21,094
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.
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