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Ascensia Diabetes Care US, Inc. recalls Contour¿ next GEN Blood Glucose Monitoring System
Recalled July 26, 2023 · FDA recall Z-2211-2023 · Ascensia Diabetes Care US
Description
Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter kit and had incorrect factory-set unit of measure where the meters display glucose results in mmol/L rather than mg/dL. The standard unit of measurement for the United States is mg/dL. If a consumer does not notice the incorrect unit of measurement, it is possible that the meters glucose measurement will be read as a lower blood glucose measurement than expected, and this may result in the patients glucose level remaining high, which can potentially lead to an injury requiring immediate medical intervention.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →