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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
Initiated
August 2, 2002
Product:
Roche Diagnostics Accu-Chek Inform Blood Glucose Monitoring System.
Use:
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.