Nova Biomedical® Announces Global Medical Device Correction for StatStrip® Glucose Hospital Meter

Nova Biomedical initiated a global Medical Device Correction on July 24, 2026, for the StatStrip Glucose Hospital Meter System (Gen 2.0 model only) due to a software defect that causes glucose results to be associated with the wrong patient. When a patient ID barcode is scanned, prior patient information may remain on the meter screen; if accepted without verification, the resulting glucose value is recorded in the wrong patient's medical record. The correction does not affect Gen 1.0, Gen 1.75, Gen 1.86, or Gen 1.87 models. Prior to recall initiation, Nova Biomedical received one adverse event report in the United States on July 17, 2026, involving inappropriate insulin administration to a patient based on a different patient's glucose results. No serious adverse events related to this issue have been reported. The affected products span six part numbers distributed in the United States, globally, and in country-specific versions for Japan, Germany, the United Kingdom, and Canada, covering all serial numbers under UDI 00385480636858 and related identifiers. Nova Biomedical has implemented a shipment hold on all affected StatStrip Glucose Hospital Meter Systems while a software update is developed and validated. The company intends to release the software update in a phased rollout beginning in November 2026. Until the update is available, Nova recommends that end users verify patient ID on the device screen after every barcode scan, confirm patient name and date of birth on the Confirm Patient ID screen before pressing Accept, and re-verify patient ID on the result screen after testing is complete. Healthcare facilities that have alternative glucose monitoring devices are directed to stop using the affected Gen 2.0 meters. Facilities without an alternative must continue manual verification steps. Adverse events and product quality problems are to be reported to Nova Biomedical and optionally to FDA MedWatch.