On June 6, 2007, the U.S. Food and Drug Administration (FDA) announced a Class I recall of the Bayer Ascensia Contour Glucose Monitoring System because certain models report the wrong units of measurement for Canadian users. Class I medical device recalls are the most severe the FDA issues, reserving the warning “for dangerous or defective products that predictably could cause serious health problems or death.”

Instead of reporting an appropriate “mmol/L” reading, Canadian users have reported the meters showing readings in “mg/dL.” The monitoring systems are used to measure glucose in blood – a critical element of diabetes management. The faulty meters may represent a value 18 times greater than the actual level.

The misreading could lead to an adjustment in treatment, which could lead to hypoglycemia, potentially leaving the patient unable to self-medicate.

The specific serial numbers of the recalled glucose monitoring systems include:

• 1475139 • 1688643 • 1841620 • 1852071 • 2064303 • 2064306 • 2064329 • 2064601 • 2086449 • 2203283 • 2221308 • 2263059 • 2263260 • 2280056 • 2317037 • 2319010

The FDA is suggesting consumers call Bayer Healthcare at 1-574-256-3441.

Source: U.S. Food and Drug Administration, “Class 1 Recall: Bayer Ascensia Contour Blood Glucose Monitoring System,” June 6, 2007. (www.fda.gov/cdrh/recalls/recall-060607.html)