Nova Biomedical removes StatStrip hospital glucose meters over patient-ID risk

Nova Biomedical has recommended that customers remove affected StatStrip Glucose Hospital Meter Systems, Gen 2.0, from use until a software update is available. The FDA said the removal applies only to the Gen 2.0 model, not previously released models such as Gen 1.86. The FDA identified the recall as the most serious type.

Nova said the issue affects Gen 2.0 meters on all firmware versions and does not affect the analytical performance of glucose measurements. If accepted, that information could cause a glucose result to be assigned to the wrong patient or quality control ID. The FDA said this could lead to treatment decisions based on another patient’s result, with critically ill patients and infants at greater risk. As of October 5, Nova had reported one serious injury and no deaths. The company plans a phased software update in November 2026 and has placed new Gen 2.0 shipments on hold.