Medical devices
FDA warns of wrong-patient readings from Nova hospital glucose meters
The Gen 2.0 meter may assign a glucose result to the wrong patient, so follow Nova’s updated instructions or stop using it if an alternative is available.
The FDA is warning hospitals about Nova Biomedical’s StatStrip Glucose Hospital Meter System, Gen 2.0, after reports that glucose results may be assigned to the wrong patient. Nova recommended updated use instructions while a software update is prepared. If an alternative meter is available, the FDA says users should stop using the affected meter until it is updated.
The issue affects the Gen 2.0 model on all versions of firmware, and does not affect the analytical performance of glucose measurements. When a patient ID or quality control barcode is scanned, prior information may remain on the screen. If accepted, the result may be recorded under the wrong patient or quality control ID, potentially leading to inappropriate treatment. Critically ill patients and infants may face greater risk.
Nova has placed a shipment hold on new Gen 2.0 meters while corrective actions are developed and validated. The company intends to roll out a software update in November 2026. As of October 5, Nova had reported one serious injury and no deaths associated with the issue. The FDA identified the recall as the most serious type.
