Recall - Nova Biomedical StatStrip (StatStrip Glucose Hospital Meter System) produced by Nova Biomedical - Software issue may cause a glucose result to be associated to the[...]

Summary

Company 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. Affected products. This recall applies to all serial numbers of the products listed below:

As a precautionary measure, Nova has implemented a shipment hold on all StatStrip Glucose Hospital Meter Systems while corrective actions are being developed and validated. Efforts are underway for the verification and validation of a software update to address this issue. Nova intends to roll out the software update in November 2026 in a phased manner. This will include measures to mitigate the issues related to the recall, as well as other non-safety-related improvements.

While this software update will mitigate known contributing factors associated with the recall, Nova will continue to monitor the performance of the StatStrip Hospital Glucose System and evaluate opportunities for additional improvements as appropriate.

While working on resolution to the patient ID issue, Nova is providing the following recommendations to end users:

• To mitigate the risk of glucose results being assigned to the wrong patient's medical record, Nova recommends the use of patient validation and operator log o software configurations available in current Statstrip Glucose Hospital meter system and NovaNet middleware.
• After every barcode scan, verify on the device that the patient ID displayed is for the patient currently being tested. Confirm that the patient name, date of birth, and other identifying information shown on the Confirm Patient ID screen correspond to the patient whose sample is being collected before pressing Accept. When the glucose result populates on the device after testing is complete, verify again that the patient ID displayed on the result screen belongs to the patient currently being tested. Do not assume that the patient ID displayed at the time of result is the same as the one verified at the time of scanning.
• If any glucose level is assigned to the incorrect patient, immediately notify your administrator. If you do not have an alternative device, you must continue to follow these mitigation steps until the software fix becomes available. If you have an alternative device, you should stop using the affected device.

More information about the Global Medical Device Correction for the StatStrip® Glucose Hospital Meter System, including detailed instructions for customers or individuals with an affected StatStrip meter can be found on the Nova Biomedical website here: https://www.novabiomedical.com/statstrip-global-medical-device-correction/.

Customer support. Customers in the United States may contact Nova Biomedical Technical Support at 1-800-545-6682. Customers in Canada may call 1-800-263-5999. Technical Support is available 24 hours a day, 7 days a week, 365 days a year. Customers outside the United States or Canada should contact their authorized Nova Biomedical distributor or local sales representative.

Reporting Adverse Events:

Healthcare professionals and customers should report adverse events or product quality problems associated with these devices to Nova Biomedical. Adverse events may also be reported to the FDA MedWatch Adverse Event Reporting Program in accordance with FDA instructions.

• Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverseevent-reporting-program
• Mail or Fax: Download forms online: https://www.fda.gov/safety/medical-productsafety-information/medwatch-forms-fda-safety-reporting or call the MedWatch Safety Reporting Hotline at1-800-332-1088 to request a form. Mail or fax the form to the FDA contact information provided on the form.

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About Nova Biomedical

Nova Biomedical develops measurement technologies that give scientists and healthcare professionals the information they need to make critical decisions. The company's clinical business develops diagnostic technologies for hospital laboratories, critical care, point-of-care, and other patient-care settings. Its portfolio includes whole-blood analysis, glucose and ketone testing, osmolality, cerebrospinal fluid cell counting, and liquid-handling verification, helping healthcare teams obtain reliable results quickly and make informed treatment decisions. Headquartered in Waltham, Massachusetts, Nova Biomedical serves customers in more than 120 countries. For more information, visit novabiomedical.com.