Ascensia Diabetes Care US, Inc. recalls Contour¿ next GEN Blood Glucose Monitoring System

Recall date

May 19, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2211-2023

FDA classification

Class II

Brand / firm

Ascensia Diabetes Care US, Inc.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Contour¿ next GEN Blood Glucose Monitoring System