medical Class II Updated 2020-01-08

Roche Diabetes Care, Inc. recalls Blood Glucose Monitoring System, Model Number 08313202001 A

Recalled Product

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 monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

Hazard / Issue

Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.

Issued by

FDA

Distribution: Nationwide (United States)

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).

View official government recall

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