Ascensia Diabetes Care US, Inc.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Ascensia Diabetes Care US, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-07-26FDA-DeviceClass IIContour¿ next GEN Blood Glucose Monitoring System
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.
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