PlainRecalls
FDA Devices Moderate Class II Ongoing

Contour¿ next GEN Blood Glucose Monitoring System

Reported: July 26, 2023 Initiated: May 19, 2023 #Z-2211-2023

Product Description

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.

Details

Units Affected
2,888 units
Distribution
Domestic: CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, & VA.
Location
Valhalla, NY

Frequently Asked Questions

What product was recalled?
Contour¿ next GEN Blood Glucose Monitoring System. Recalled by Ascensia Diabetes Care US, Inc.. Units affected: 2,888 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 26, 2023. Severity: Moderate. Recall number: Z-2211-2023.