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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

Hazard
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. · FDA Class II
Units
2,888 units
Sold at
Domestic: CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, & VA.

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.

Product
Contour¿ next GEN Blood Glucose Monitoring System
Manufacturer(s)
Ascensia Diabetes Care US, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Ascensia Diabetes Care US, Inc. recalls Contour¿ next GEN Blood Glucose Monitoring System | RecallWatchUSA