Nova Biomedical of Waltham, Massachusetts, has issued a global correction for its StatStrip Glucose Hospital Meter System because a software problem may cause a blood sugar result to be assigned to the wrong patient. The U.S. Food and Drug Administration (FDA) posted the company announcement on October 6, 2026. The correction began on July 24, 2026, after one patient in the U.S. received insulin based on another patient’s glucose reading.
What’s Being Recalled?
The correction applies to all serial numbers of the newest model of the StatStrip Glucose Hospital Meter System, commonly known as the “Gen 2.0” model. In the U.S., the affected products are the StatStrip Glucose Hospital Meter System (part number 63685) and its multipack version (part number 66739). Several versions of the StatStrip Glucose and Beta-Ketone Meter sold outside the U.S. are also included. Older models, known as Gen 1.0, Gen 1.75, Gen 1.86, and Gen 1.87, are not affected. These meters are used by hospitals and healthcare providers and are not sold to consumers for home use.
Why Was This Product Recalled?
When a nurse or other healthcare worker scans a patient’s ID barcode, information from the previous patient may stay on the meter’s screen. If that information is accepted, the glucose result can be saved to the wrong patient’s medical record. Providers could then make treatment decisions based on someone else’s blood sugar. That could mean delayed treatment, unnecessary treatment such as insulin, or a missed problem for the patient who was actually tested. Nova received one report of a patient being given insulin based on another patient’s results. No serious adverse events have been reported.
What Should You Do?
Nova has paused shipments of the meters and plans to release a software fix in November 2026. In the meantime, it is telling healthcare workers to confirm the patient’s name, date of birth, and other details on the screen after every scan and again when the result appears. Facilities with another device available should stop using the affected meters. If you or a loved one is in the hospital and having blood sugar checked, it is reasonable to ask staff to confirm your identity at each test. Hospital customers can reach Nova Biomedical Technical Support at 1-800-545-6682, 24 hours a day.
