Screen retention errors can misassign patient glucose results in electronic records, leading to one reported injury and a planned software update.
Nova Biomedical has issued updated instructions for its StatStrip Glucose Hospital Meter System Gen 2.0 after identifying a software issue that could cause blood glucose results to be assigned to the wrong patient’s electronic medical record (EMR).
According to the US Food and Drug Administration (FDA), the issue can occur when information from a previous patient or quality control test remains displayed after a new barcode scan. If the operator does not recognize the discrepancy, a glucose result may be recorded under the wrong patient or quality control record.
The FDA has classified the correction as a Class I recall, its most serious category. As of October 5, 2026, one serious injury and no deaths had been reported in connection with the issue.
Potential Clinical Risks
Assigning a blood glucose result to the wrong patient record creates substantial risks for clinical decision-making. Healthcare providers relying on inaccurate data may delay necessary interventions, fail to treat the intended patient, or administer inappropriate medical therapy, including incorrect insulin dosing.
According to regulatory notices, the severity of potential harm varies based on a patient’s actual glycemic status and underlying condition, with critically ill individuals and infants—who cannot communicate symptoms of hypoglycemia—facing the highest risk of adverse outcomes.
Nova Biomedical noted that the defect affects Gen 2.0 systems across all firmware versions, but emphasized that the issue does not affect the analytical accuracy or performance of the meter’s glucose measurements.
Affected Systems and Interim Actions
The issue affects only the StatStrip Glucose Hospital Meter System Gen 2.0 (model number 63685) and the Glucose Hospital Meter System Multipack (model number 66739). Earlier generations of the StatStrip Glucose Hospital Meter System are not affected.
The FDA advises healthcare facilities with alternative glucose meters to stop using affected StatStrip Gen 2.0 devices until a software update is available. For clinical laboratories and point-of-care teams without access to alternative meters, Nova Biomedical has issued updated instructions recommending the following precautions:
- Enable the “Validate Patient ID’s” setting in NovaNet for facilities using integrated admission, discharge, and transfer (ADT) data within their EMR systems.
- Configure meter logoff settings in NovaNet by selecting “Test” mode under Operator Logoff Mode to automatically log operators out after each individual test.
- Visually confirm patient identification details—including name, date of birth, and ID number—both immediately following the barcode scan and again when the test result appears on the screen before accepting the data.
- Immediately flag or remove any test results misassigned in an EMR following facility protocol, notify the clinical care team, and alert device administrators.
Software Remediation and Distribution Hold
In response to the findings, Nova Biomedical implemented a voluntary shipment hold on all new StatStrip Gen 2.0 meter systems while developing and validating corrective actions.
Verification and validation efforts are currently underway for a software update designed to resolve the display retention error and deliver non-safety-related refinements, with a phased rollout scheduled to begin in November 2026.
US facilities experiencing device problems or adverse events are urged to report them to the FDA MedWatch safety reporting program or contact Nova Biomedical technical support directly.
