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Medical Device Recalls
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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. |
For additional information on this product recall, see the
FDA Enforcement Report located at http://www.fda.gov/bbs/topics/enforce/2002/ENF00758.html. Scroll down “Recalls and Field Corrections: Devices – Class II.” |
Updated 12/17/2002
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