Nova Biomedical has initiated a global medical device correction for its StatStrip Glucose Hospital Meter System after identifying a software issue that could cause a glucose test result to be associated with the wrong patient's medical record. The U.S. Food and Drug Administration (FDA) published the company's safety announcement on October 6, 2026.
The issue involves the Gen 2.0 version of the StatStrip Glucose Hospital Meter System. According to the company, when a patient's identification barcode is scanned, information from a previously scanned patient may remain displayed on the meter. If that information is accepted without verification, the glucose result could subsequently be assigned to another patient's medical record.
Wrong-patient glucose result could affect treatment
The software issue could potentially result in healthcare professionals making clinical decisions using another patient's glucose reading.
Depending on the patient's actual glucose level and clinical condition, this could lead to delayed treatment, unnecessary treatment or failure to treat the intended patient. The FDA-posted announcement specifically notes the possibility of inappropriate insulin administration if an incorrect glucose result is used to make a treatment decision.
Nova Biomedical reported that it received one adverse event report in the United States on July 17, 2026, involving inappropriate insulin administration to a patient based on another patient's glucose result. The company stated that no serious adverse events related to the issue have been reported.
Which StatStrip meters are affected?
The correction applies to the Gen 2.0 StatStrip Glucose Hospital Meter System and associated products listed by Nova Biomedical. The affected product numbers include:
• 63685 – StatStrip Glucose Hospital Meter System
• 66739 – StatStrip Glucose Hospital Meter System Multipack
• 63683 – StatStrip Glucose and β-Ketone Meter
• 63726 – StatStrip Glucose and β-Ketone Meter, Japan
• 63910 – StatStrip Glucose and β-Ketone Meter, UK/Canada version
• 66249 – StatStrip Glucose and β-Ketone Meter (Rilibäk), Germany
The correction covers all serial numbers of the listed products. Distribution includes the United States and multiple countries worldwide.
The company clarified that the issue does not affect earlier StatStrip generations, including Gen 1.0, Gen 1.75, Gen 1.86 and Gen 1.87 systems.
Nova places shipment hold on affected systems
As a precaution, Nova Biomedical has placed a shipment hold on StatStrip Glucose Hospital Meter Systems while corrective measures are being developed and validated.
The company is working on a software update intended to address the issue and has said that the update is expected to be rolled out in a phased manner beginning in November 2026.
FDA records show Class I recalls for affected products
The FDA's medical-device recall database separately lists affected StatStrip products under Class I recalls, the FDA's most serious recall classification. The records identify the problem as a software synchronization/timing issue involving barcode scanning and patient-data processing.
The FDA records show worldwide distribution of affected products, including the United States and several international markets.
What healthcare facilities should know
The issue is particularly important because hospital glucose meters are frequently used to guide treatment decisions, including insulin administration. An incorrectly assigned glucose result could therefore affect the treatment of the intended patient.
Hospitals and healthcare facilities using Gen 2.0 StatStrip systems should review their devices against the affected product information and follow Nova Biomedical's interim verification procedures while awaiting the software update.
The FDA announcement is a company-issued safety communication posted by the agency as a public service; the FDA notes that posting the announcement does not constitute an endorsement of Nova Biomedical or its products.
