A software issue can cause glucose results to be assigned to the wrong patient’s medical record. One serious injury has been reported, and a fix is expected in November.

Nova Biomedical is removing its StatStrip Glucose Hospital Meter System (Gen 2.0) from use and sale while the company develops a software fix for a defect that can cause glucose results to be assigned to the wrong patient.

The US Food and Drug Administration has identified the action as its most serious type of recall, warning that continued use of the device may cause serious injury or death. As of Oct 5, Nova Biomedical has reported one serious injury and no deaths associated with the issue.

The removal applies only to the Gen 2.0 model of the StatStrip Glucose Hospital Monitoring System and does not affect previously released models, including the Gen 1.86. Affected devices include the StatStrip Glucose Hospital Meter System (model 63685) and the Glucose Hospital Meter System Multipack (model 66739).

Reason for the Recall

Nova Biomedical received reports from customers that when scanning patient ID or quality control (QC) barcodes, prior information may remain on the meter screen. If accepted, the glucose result is assigned to the wrong patient’s medical record or QC ID.

If the error is not recognized, clinicians may make treatment decisions based on another patient’s glucose result, potentially leading to delayed treatment, unnecessary treatment including inappropriate insulin administration, or failure to treat the intended patient. Critically ill patients and infants, who may be unable to communicate symptoms of hypoglycemia, are at greater risk of adverse outcomes.

The issue affects Gen 2.0 systems operating on all versions of firmware and does not impact the analytical performance of glucose measurements, according to Nova Biomedical.

Interim Mitigation Steps

Nova Biomedical sent an initial notification to affected customers on July 31 and issued an updated letter on Oct 5. The company advises facilities with an alternative device to stop using the affected meters. Facilities without an alternative device should follow the interim mitigation steps until a software fix becomes available:

  • For customers whose electronic medical record (EMR) systems include integrated Admission, Discharge, and Transfer (ADT) information, confirm that the “Validate Patient ID’s” setting is enabled within NovaNet. This feature is only available to customers using ADT with their systems.
  • Configure StatStrip Glucose Hospital Meters to automatically log the operator out after each test by selecting “Test” mode under the “Operator Logoff Mode” dropdown in the NovaNet Logoff Setup menu.
  • After every barcode scan, verify on the device that the displayed patient ID, name, date of birth, and other identifying information match the patient being tested before pressing Accept. Verify the patient ID again when the glucose result populates, and do not assume the ID shown at the time of result matches the one verified at scanning.
  • If a glucose level is assigned to the wrong patient, immediately notify an administrator. Facilities without an alternative device must continue following the mitigation steps until the software fix is released; facilities with an alternative device should stop using the affected meter.
  • Any glucose result incorrectly assigned to a patient’s medical record should be flagged or removed promptly, following facility procedures for correcting erroneous EMR entries, and the treating clinical team should be notified.

Shipment Hold and Software Update Timeline

As a precautionary measure, Nova has implemented a shipment hold on all new Gen 2.0 StatStrip Glucose Hospital Meter Systems while corrective actions are being developed and validated. The company says verification and validation of a software update are underway, with a phased rollout planned for November 2026. The update will address the recall-related issue along with other non-safety-related improvements.

Device Use and Contact Information

The StatStrip Glucose Hospital Meter is a hand-held, battery-powered, in vitro diagnostic instrument that works with Nova Biomedical glucose electrochemical test strips to measure glucose in whole blood or a QC solution. The meter also stores patient test data, QC data, and information related to the patient, sample, operator, reagents, and the device.

Customers in the US with adverse reactions, quality problems, or questions about the recall can contact Nova Biomedical at 1-800-545-6682.