PharmacovigilanceOfficial

FDA flags most serious recall of Nova StatStrip Gen 2.0 glucose meters over patient misassignment

🇺🇸 FDA MedWatch · Fri 30 Oct 2026

Nova Biomedical's Gen 2.0 hospital meters can retain prior patient or QC information on screen, risking results being filed to the wrong record; a software fix is planned for November 2026.

The US Food and Drug Administration has classed a Nova Biomedical correction affecting the StatStrip Glucose Hospital Meter System as the most serious type of recall, warning that continued use without correction may cause serious injury or death. The action covers only the newest Gen 2.0 model, running on all firmware versions; earlier StatStrip models are not affected. Affected products are model 63685 (the meter system) and model 66739 (the multipack), both listed under UDI/DI 00385480636858.

Nova says that when a patient ID or quality control barcode is scanned, information from a previous scan can stay on the meter screen. If a user accepts it, the glucose result is attached to the wrong patient's record or QC ID. The company stresses that analytical performance of the glucose measurement is not affected. The risk lies in clinicians acting on another patient's result, which could mean delayed or unnecessary treatment, including inappropriate insulin administration, or failure to treat the intended patient. Critically ill patients and infants are at greater risk because they may be unable to communicate hypoglycaemia symptoms.

Nova sent an initial customer letter on 31 July and updated it on 5 October. Interim measures are: where the EMR includes integrated ADT information, enable the 'Validate Patient ID's' setting in NovaNet; configure meters to log the operator out after every test; and check on the device, after each barcode scan and again when the result appears, that the displayed patient ID matches the patient being tested. Users should not assume the ID shown at result stage is the one verified at scanning. Misassigned results must be reported to an administrator, flagged or removed from the record, and the treating team told, following local EMR correction procedures.

Where an alternative meter is available, customers should stop using the affected StatStrip until it is updated; those without one must keep applying the mitigations. Nova has placed a shipment hold on new Gen 2.0 systems and plans a phased software rollout in November 2026, which will also include non-safety improvements. As of 5 October, the company had reported one serious injury and no deaths. US customers can contact Nova on 1(800) 545-6682.

What it means for your team

  • Hospital QA and device-safety teams should confirm whether Gen 2.0 meters (models 63685, 66739) are in use and verify NovaNet settings for ADT patient validation and test-level operator logoff.
  • Where substitute meters exist, the FDA advises withdrawing affected units until updated; sites without them need documented, enforced bedside ID checks at both scan and result stages.
  • Pharmacovigilance and risk staff should set up a route for reporting and correcting misattributed results in the EMR, and for notifying clinical teams and Nova.
  • Plan for the phased November 2026 software update, including validation and change-control steps once it becomes available.

Official source: FDA MedWatch ↗

Article written by VigiEye from the official source (FDA MedWatch). AI-assisted; check the source before acting.

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