Ascensia Diabetes Care US Inc.
FDA adverse event reports naming Ascensia Diabetes Care US Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ASCENSIA DIABETES CARE US INC..
- Total reports
- 3,583
- Deaths
- 1
- Injuries
- 536
- Malfunctions
- 3,046
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- System, Test, Blood Glucose, Over The CounterNBW3,097
- Single (Specified) Analyte Controls (Assayed And Unassayed)JJX433
- Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK26
- Automated Insulin Dosing Device System, Single Hormonal ControlOZP9
- Multiple Use Blood Lancet For Single Patient Use OnlyQRL9
- Nitroprusside, Ketones (Urinary, Non-Quant.)JIN3
- Glucose Dehydrogenase, GlucoseLFR3
- Automated Insulin Dosing , Threshold SuspendOZO2
- Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL1
Recent recalls
- 2023-07-20Open, ClassifiedProcess control
Contour 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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