Nova Biomedical recalls StatStrip Glucose Hospital Meter System over software issue that can mix up patients' results

Official notice

The notice's own wording from FDA.

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

Announcement

WALTHAM, Mass., October 5, 2026 – Nova Biomedical initiated a global Medical Device Correction on July 24, 2026, for the StatStrip® Glucose Hospital Meter System due to a software issue that may cause a glucose result to be associated with the wrong patient. When a patient ID barcode is scanned, prior patient information may remain on the meter screen, which if accepted, will lead to glucose result being assigned to the wrong patient’s medical record. 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. This issue only applies to the most recent model of the StatStrip Glucose Hospital Meter System, commonly referred to as the “Gen 2.0” model. This issue does not affect previously released models of the StatStrip Glucose Hospital Meter system, commonly referred to as the “Gen 1.0”, “Gen 1.75”,” “Gen 1.86”, or “Gen 1.87” StatStrip Glucose Hospital Meter systems. On July 17, 2026, prior to the recall initiation, Nova Biomedical received one (1) report of an adverse event (AE) in the U.S. (none outside of the U.S.) associated with this issue. This AE involved 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.