FDA Announces Bayer Recall of Blood Glucose Monitoring System

The FDA July 16 issued a MedWatch notice announcing that Bayer Healthcare initiated a Class 1 recall of its Ascensia Contour blood glucose monitoring system.

The product was recalled because the meters reported the wrong units of measure for Canadian users, the agency said. 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, overestimating blood glucose levels, and may have a reaction of hypoglycemia, according to the FDA.

The complete MedWatch summary and a link to the manufacturer’s recall notice can be found at www.fda.gov/medwatch/safety/2007/safety07.htm#ascencia.