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Sign in to claim this brandASCENSIA DIABETES CARE US INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 100 Summit Lake Drive, Valhalla, NY, 10595
- Website
- contournext.com
- —
- —
- [email protected]
- Phone
- 18003488100
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1810909
- DUNS Number
- 080028910
Catalogue (101)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Contour Next EZ Blood Glucose Monitoring System | K162336 | FDA 510(k) | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 19, 2023 | Z-2211-2023 | — | open, classified | 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. |