Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues
Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues that may affect device performance.
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. While the source does not explicitly state reported illnesses, the hazard involves a medical device used for critical glucose monitoring where power issues could lead to inaccurate readings and potential harm, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Roche Diabetes Care, Inc. is recalling the Accu-Chek Guide Blood Glucose Monitoring System, Model Number 07400926001, due to potential power issues. The recall affects 215,259 units distributed nationwide in the United States and in numerous international markets, including Canada, Australia, and various European and Asian countries.
The affected devices are identified by Model Number 07400926001 and Device Identifier 00365702702042. Specifically, the recall includes units with serial numbers below XXX11000001, where XXX represents the first three digits of the serial number. The Accu-Chek Guide system is intended for in vitro diagnostic single-patient use by people with diabetes to measure glucose in fresh capillary whole blood.
Consumers should stop using the affected devices and contact Roche Diabetes Care for further instructions or 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, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL 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.
- Affected units
- 215,259
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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