ASCENSIA DIABETES CARE HOLDINGS AG
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
Devices registered here (1)
- System, Test, Blood Glucose, Over The CounterProduct code NBW (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345
Recalls & enforcement
- Class IIOngoing2023-05-19Ascensia 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 o…
Related
- All facilities operated by Ascensia Diabetes Care Holdings AG
- Ascensia Diabetes Care US Inc. (NJ)
- Ascensia Diabetes Care US Inc. (NY)
- Ascensia Diabetes Care Poland Sp. z o.o. (PL)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “ASCENSIA DIABETES CARE HOLDINGS AG (FEI 3012118659) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012118659-ascensia-diabetes-care-holdings-ag/
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