Ascensia Diabetes Care US Inc.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- Automated Insulin Dosing , Threshold SuspendProduct code OZO (opens in a new tab) · Class III · Unknown
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…
FDA inspections (1)
- NAI2017-08-07No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
- All facilities operated by Ascensia Diabetes Care Holdings AG
- Ascensia Diabetes Care US Inc. (NJ)
- ASCENSIA DIABETES CARE HOLDINGS AG (CH)
- 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 US Inc. (FEI 1810909) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1810909-ascensia-diabetes-care-us-inc/
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