Recall Z-2211-2023 · NBW System, Test, Blood Glucose, Over The Counter
Ascensia Diabetes Care US, Inc.
Contour next GEN Blood Glucose Monitoring System
| Date | Jul 20, 2023 (initiated May 19, 2023) |
| Status | Open, Classified |
| 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 expe |
| Root cause | Process control |
| Action | The firm sent recall notifications to customers dated 06/21/2023. Customers are asked to check their personal meters and entities are asked to check their stock to identify any affected devices. If you are aware of any patients or customers downstream who have received a recalled device make them aware of this recall. Anyone with a recalled unit can contact the firm at 1-800-348-8100 or by email at support@contournext.com to initiate return and replacement of devices. Response Forms were provided for customers to return via email to qualitysupport@ascensia.com. |
| Quantity | 2,888 units |
| Distribution | Domestic: CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, & VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193407 | Contour® next GEN Blood Glucose Monitoring System Ascensia Diabetes Care, Dec 23, 2021 |