# FDA recall Z-2211-2023

> **Ascensia Diabetes Care US, Inc.** · Class II · device recall initiated 2023-05-19.

## Product

Contour¿ next GEN Blood Glucose Monitoring System

## Reason for recall

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.

## Distribution

Domestic: CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, & VA.

## Key facts

- **Recall number:** Z-2211-2023
- **Recalling firm:** Ascensia Diabetes Care US, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-19
- **Report date:** 2023-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Valhalla, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2211-2023

## Citation

> AI Analytics. FDA recall Z-2211-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2211-2023. Source: US FDA. Licensed CC0.

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