Contour¿ next GEN Blood Glucose Monitoring System — Class II medical device recall Z-2211-2023
Ongoing recall by Ascensia Diabetes Care US, Inc., reported 2023-07-26, distributed in CA, CO, FL, IN, MO, NJ, NY, OH…. Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01
| Recall number | Z-2211-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascensia Diabetes Care US, Inc., Valhalla, NY, United States |
| Recall initiated | 2023-05-19 |
| Classified | 2023-07-20 |
| Reported by FDA | 2023-07-26 |
| Distributed | CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, VA |
| Quantity | 2,888 units |
| UPC / GTIN / UDI-DI | 00301937917011 |
| Lot numbers | DM01T033P |
| Serial numbers | 1057018, 1057019, 1057020, 1057023, 1057024, 1057025, 1057076, 1057077, 1057078, 1057079, 1057080, 1057081, 1057082, 1057083, 1057084, 1057085, 1057086, 1057087, 1057088, 1057089, 1057090, 1057091, 1057092, 1057093, 1057094 and 475 more |
| Model numbers | 7917 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2211-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.