Medical devices
Nova Biomedical corrects StatStrip glucose meters over wrong-patient risk
The software issue affects Gen 2.0 meters and may associate a glucose result with the wrong patient.
Nova Biomedical initiated a global medical device correction on July 24, 2026, for the StatStrip Glucose Hospital Meter System. The software issue affects the newest model, called Gen 2.0. After a patient ID barcode is scanned, prior patient information may remain on the screen. If accepted, a glucose result can be assigned to the wrong patient’s medical record, potentially leading to delayed treatment, unnecessary treatment or failure to treat the intended patient.
The FDA MedWatch notice says Nova received one (1) U.S. adverse event report on July 17, 2026, involving inappropriate insulin administration based on another patient’s glucose results. No serious adverse events related to the issue have been reported. The correction does not affect Gen 1.0, Gen 1.75, Gen 1.86 or Gen 1.87 meters. Nova has placed a shipment hold on all StatStrip Glucose Hospital Meter Systems while it validates a software update, which it plans to roll out in November 2026 in a phased manner.
