Contour¿ next GEN Blood Glucose Monitoring System — FDA record Z-2211-2023

What the record says

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.

Classification

Class II

Recalling firm

Ascensia Diabetes Care US, Inc.

Quantity

2,888 units

Agency-reported status

Ongoing

Source record identifier

Z-2211-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

• California
• Colorado
• Florida
• Indiana
• Missouri
• New Jersey
• New York
• Ohio
• Rhode Island
• South Carolina
• Tennessee
• Texas
• Virginia

Dates in the source

Report date

Jul 26, 2023

Recall initiation date

May 19, 2023

Center classification date

Jul 20, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.