FDA Device recall Z-2211-2023

Contour¿ next GEN Blood Glucose Monitoring System

• FDA Device
• Class II
• ongoing
• Published 2023-07-26

On 2023-07-26 the FDA classified a Class II recall of Contour¿ next GEN Blood Glucose Monitoring System by Ascensia Diabetes Care Us, citing 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 d….

Read the official FDA Device notice

Product

Contour¿ next GEN Blood Glucose Monitoring System

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2211-2023%22

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