Nova Biomedical is correcting every Gen 2.0 StatStrip hospital glucose meter because a software flaw can file one patient’s blood sugar reading under another patient. The company has 71 reports, one U.S. adverse event involving insulin, and a software fix planned for November.
How the Software Flaw Works
Nurses scan a patient’s wristband barcode before each test. According to Nova’s customer advisory notice, the previous patient’s information can stay on the screen after a new scan. If staff accept it, the meter assigns the result to the wrong patient’s record.
The notice says the problem affects all software versions and does not affect analytical performance. In Nova’s description the meter measures glucose as designed. The result lands in the wrong chart.
Nova lists the possible harms as delayed treatment, unnecessary treatment including inappropriate insulin, and failure to treat the intended patient. It says critically ill patients and infants face greater risk because they may be unable to report symptoms of low blood sugar.
The notice describes a single serious case. On July 17, 2026, Nova received one U.S. adverse event report involving insulin given on the basis of another patient’s glucose result. The company says no serious adverse events related to the issue have been reported beyond that.
Which Meters Are Affected
Only the newest model, known as Gen 2.0, is covered. Nova says Gen 1.0, Gen 1.75, Gen 1.86 and Gen 1.87 are not affected. In the United States the correction applies to part 63685, the StatStrip Glucose Hospital Meter System, and part 66739, the multipack, which share device identifier 00385480636858. Every serial number is included.
FDA published the announcement on Oct. 6. Its version lists four more products sold outside the United States. They include glucose and ketone meters for Japan and Germany, a UK and Canada version and a global version that excludes the United States. FDA’s posting says the announcement does not state how many devices are affected.
The two documents give different pictures of the problem’s size. Nova’s customer notice reports 71 customer reports and calls the rate low relative to devices in the field. The FDA posting mentions only the one U.S. adverse event and gives no count of reports.
What Hospitals Are Told to Do
Nova placed a shipment hold on all StatStrip Glucose Hospital Meter Systems while it develops and validates a fix. It started the global correction on July 24. The company plans a phased software rollout in November 2026, which will also include some improvements unrelated to safety. From the start of the correction to the first November rollout date is about 14 weeks.
Until then, the notice gives hospitals a list of steps. Sites with an integrated admission, discharge and transfer feed in their electronic records should turn on the “Validate Patient ID’s” setting in the NovaNet middleware. All sites should set the operator logoff mode to “Test.” Staff should confirm the patient’s name, birth date and other identifiers before pressing Accept and check the ID again on the result screen.
The notice states the key warning in one line: “Do not assume that the patient ID displayed at the time of result” matches the one confirmed at scanning, according to the FDA posting. Staff should flag or remove any misassigned result so clinicians do not use it, and correct the electronic record. Hospitals with an alternative device can stop using the affected meter. Those without one should continue the safeguards until the update arrives.
Nova first sent a notice in July. The revision dated Oct. 5, marked Rev. 2, replaces it and clarifies customer actions. Customers must return the revised acknowledgment form even if they sent back the original.
What the Numbers Show
The company’s figures are small next to a hospital’s testing volume, but they say something about how the flaw surfaces. Seventy-one reports and one insulin event mean about 1.4% of the reports describe the harm Nova worries about most. Nova says the rate is low relative to devices in the field and does not give a device count in either document.
The timing is also on the record. The correction began July 24, and Nova’s first notice went out in July. The revision with tighter instructions came Oct. 5, roughly 10 weeks after the correction began. FDA posted it the next day. The company has held shipments of the Gen 2.0 system since the correction began, so Nova is not shipping new units of this model while the update is validated.
Nova’s revised notice adds administrative steps for hospital staff. Each facility must give copies to all end users and post the notice where meters are stored and used. Acknowledgment forms go to a regional address for North America, Europe and affiliated EU countries, or all other international customers.
How to Reach Nova
Nova’s technical support line is 1-800-545-6682 in the United States and 1-800-263-5999 in Canada, available around the clock. Customers elsewhere should contact their authorized distributor. The company signed the notice through Julie MacKenzie, vice president of clinical business, and Autumn Collasius, senior vice president of quality and regulatory.
Anyone who sees a problem with a StatStrip meter can report it to Nova or to FDA’s MedWatch program, at 1-800-332-1088. Nova’s technical support lines operate 24 hours a day, seven days a week, so a hospital that finds a misassigned result at night can call at once. Nova also says it is reviewing the issue and will make regulatory notifications where warranted.
