StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Published January 1, 2025 · Recall initiated: November 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Nova Biomedical Corporation
- Distributor
- Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
- Lot
- Model No 63685. UDI-DI (01)10385480636858. Software Versions: v0.0.13.10 to v0.0.13.44
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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