Blood Glucose Meters Display Glucose Levels in Wrong Unit of Measure

Plain-English summary

Ascensia Diabetes Care US, Inc. is recalling blood glucose meters from the Contour® next GEN system, Model 7917, Lot Number DM01T033P. A total of 2,888 meters are affected, with 579 distributed in the United States across California, Colorado, Florida, Indiana, Missouri, New Jersey, New York, Ohio, Rhode Island, South Carolina, Tennessee, Texas, and Virginia.

The affected meters are factory-configured to display blood glucose measurements in mmol/L (the metric unit) instead of mg/dL (the standard U.S. unit). If a patient does not notice this unit discrepancy, the glucose reading may be misinterpreted as lower than the actual blood glucose level.

Misreading blood glucose levels in this manner could result in a patient's blood glucose level remaining elevated without appropriate treatment. This may potentially lead to an injury requiring immediate medical intervention. The FDA has classified this recall as Class II.

The recalled product

Product

Contour¿ next GEN Blood Glucose Monitoring System

Manufacturer

Ascensia Diabetes Care US, Inc.

Category

Medical Device — Blood Glucose Meter

Hazard

• unit-of-measure-error
• glucose-misreading
• hyperglycemia-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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