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U.S. Department of Health and Human Services

Medical Devices

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Accu-Chek Inform Blood Glucose Monitoring System

Class II Recall

Date Recall
August 2, 2002
Roche Diagnostics Accu-Chek Inform Blood Glucose Monitoring System.
To monitor blood glucose readings and provide recordkeeping for quality control of blood glucose results. It is sold for professional use only in the U.S. and is used in a hospital setting.
Recalling Firm:
Roche Diagnostics Corporation
9115 Hague Road
Indianapolis, IN 46250
Reason for Recall:
Inaccurate blood glucose readings of up to 35% in either direction might result if the meter has ever displayed the temperature icon when in use.
Public Contact:
Debara R. Reese
Vice President, Regulatory Compliance
Roche Diagnostics Corporation
P.O. Box 50457
Indianapolis, IN 46250
Phone: 317-576-3857
FDA District:
Detroit, Michigan
FDA Comment:
FDA considers there to be a risk of significant incorrect blood glucose monitor readings if the temperature icon has ever been displayed in conjunction with patient use.