Recall Z-2211-2023— Ascensia Diabetes Care US, Inc.

Name: FDA recall Z-2211-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-19

Class II · Ongoing

Class II FDA medical device recall by Ascensia Diabetes Care US, Inc., initiated 2023-05-19. It names one FDA 510(k) clearance: K193407. 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..

Recalling firm: Ascensia Diabetes Care US, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-05-19
Firm location: Valhalla, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K193407 — Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care·cleared 2021-12-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.