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 upper arm as an aid in mon
Check against the official notice below — it lists the full affected range.
Roche Diabetes Care, Inc. is recalling the Accu-Chek Guide Blood Glucose Monitoring System, Model Number 08453063001, due to potential power issues with the device. The recall affects 355,400 units distributed nationwide in the United States and internationally across multiple countries including Canada, Australia, Japan, India, and many others. The affected devices are those with serial numbers below XXX11000001, where XXX represents the first three digits of the serial number.
The recall notice does not specify what consumers should do regarding the affected devices or provide information about a remedy or replacement program.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Reason for recall: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Distribution: US Nationwide distribution and countries of 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, ZA. Quantity: 355,400 Lot/code info: Model Number : 08453063001 Device Identifier: 00365702728103 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.