Nova Biomedical Says a Software Issue May Cause a StatStrip Glucose Result to Be Associated With the Wrong Patient

Nova Biomedical announced on October 5, 2026, that it had initiated a global Medical Device Correction on July 24, 2026, for its StatStrip Glucose Hospital Meter System, "due to a software issue that may cause a glucose result to be associated with the wrong patient." The FDA posted the company's announcement the next day. The page says the FDA posts such announcements "as a public service" and does not endorse either the product or the company. Parts of the announcement follow, not the whole.

The Software Issue

"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 company says the issue applies only to the most recent model of the system, commonly referred to as the "Gen 2.0" model, and does not affect previously released models.

On July 17, 2026, before the recall was initiated, the company received "one (1) report of an adverse event (AE) in the U.S." associated with the issue. That event involved inappropriate insulin administration to a patient based on a different patient's glucose results. The company says no serious adverse events related to the issue have been reported.

The screen that should confirm the patient is the screen that can show the wrong one. Nothing in the announcement says the meter flags the mismatch itself.

Until the Software Update

As a precautionary measure, the company said, it had implemented a shipment hold on all StatStrip Glucose Hospital Meter Systems "while corrective actions are being developed and validated." It said it "intends to roll out the software update in November 2026 in a phased manner." The company said the update will mitigate known contributing factors associated with the recall, and that it will continue to monitor the system's performance and evaluate opportunities for additional improvements as appropriate.

While it works on the issue, the company gives end users a set of recommendations. It recommends the use of patient validation and operator log-on configurations available in the current system and its middleware. After every barcode scan, users should verify on the device that the patient ID displayed is for the patient currently being tested, before pressing Accept, and verify again on the result screen when the glucose result populates. "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 a glucose level is assigned to the incorrect patient, users should immediately notify their administrator. Users without an alternative device must continue to follow these mitigation steps until the software fix becomes available. Users who have an alternative device, the company says, should stop using the affected one.