Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - 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 monit
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 08313202001, due to potential power issues with the device. The recall affects approximately 452,392 units distributed nationwide in the United States and in numerous countries including Canada, Australia, Japan, and others. The affected devices are identified by serial numbers below XXX11000001, where XXX represents the first three digits of the serial number.
The recall notice does not specify a remedy or instructions for what affected consumers should do.
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: 452,392 Lot/code info: Model Number : 08313202001 Device Identifier: 00365702702349 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.