StatStrip Glucose Hospital Meter System
Product details
- StatStrip Glucose Hospital Meter System
Company announcement
Nova Biomedical initiated a global Medical Device Correction on July 24, 2026, for the StatStrip Glucose Hospital Meter System due to a software issue.
This issue affects the 'Gen 2.0' model, distributed globally, including the United States.
One adverse event involving inappropriate insulin administration was reported in the United States, but no serious adverse events or deaths have been reported.
A software update is planned for November 2026 to mitigate the issue.
Risk:
The software issue may cause a glucose result to be associated with the wrong patient. If not recognized, healthcare providers may make clinical decisions based on another patient’s glucose result, potentially leading to delayed treatment, unnecessary treatment (including inappropriate insulin administration), and/or failure to treat the intended patient. The severity of harm depends on the patient’s actual glucose status and clinical condition.
Impacted states: Nationwide
Products:
- StatStrip Glucose Hospital Meter System
- StatStrip Glucose Hospital Meter System (Multipack)
Contact
For more information, call 1-800-545-6682.