Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Contour¿ next GEN Blood Glucose Monitoring System Recalled by Ascensia Diabetes Care US, Inc. Due to Ascensia Diabetes Care has determined through customer complaints...

Date: May 19, 2023
Company: Ascensia Diabetes Care US, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ascensia Diabetes Care US, Inc. directly.

Affected Products

Contour¿ next GEN Blood Glucose Monitoring System

Quantity: 2,888 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 13 states: CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, VA

Affected (13 states)Not affected

About Ascensia Diabetes Care US, Inc.

Ascensia Diabetes Care US, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report