Roche Diabetes Care, Inc. recalls Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The…

Recall date

September 30, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0751-2020

FDA classification

Class II

Brand / firm

Roche Diabetes Care, Inc.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 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.