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U.S. Department of Health and Human Services

Safety

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Bayer Ascensia Contour Blood Glucose Monitoring System

Audience: Endocrinologists, healthcare professionals, diabetic patients, and pharmacies

[Posted 07/13/2007] Bayer Healthcare and FDA notified healthcare professionals and consumers of a Class 1 Recall of Bayer Ascensia Contour Blood Glucose Monitoring System, Product 7152A. This system is used by diabetic patients to measure the amount of glucose in their blood, and as an aid in monitoring the effectiveness of diabetes management.

The product was recalled because the meters reported the wrong units of measure for Canadian users. Instead of mmol/L, which is the appropriate measurement for Canadian users, the meters were reporting mg/dL. Consumers may misinterpret the blood glucose results displayed, overestimate the blood glucose levels, and may have a reaction of hypoglycemia. Patients with questions should call Bayer Healthcare at 1-574-256-3441.

[July 13, 2007 - Recall Notice - FDA]