FDA Names Nova Biomedical StatStrip Hospital Glucose Meter Removal a Class I Recall

The US Food and Drug Administration has identified Nova Biomedical's removal of its newest StatStrip Glucose Hospital Meter Systems as a Class I recall, the agency's most serious type, after reports that the meters can assign a glucose result to the wrong patient's medical record.

In a MedWatch notice sent on October 20, the FDA said it is aware that Nova Biomedical has issued a letter to affected customers "recommending that all affected StatStrip Glucose Hospital Meters be removed from where they are used or sold until a software update becomes available." The notice states: "This device may cause serious injury or death if you continue to use it."

Prior scan data left on screen

According to the FDA, Nova Biomedical has received customer reports that when staff scan a patient ID or quality control (QC) barcode, information from a prior scan may remain on the meter screen. If that information is accepted, a glucose result will be assigned to the wrong patient's medical record or QC ID.

If the error is not recognised, the FDA said, "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 agency said critically ill patients and infants, who may be unable to communicate symptoms of hypoglycemia, are at greater risk of adverse outcomes. "The severity of harm depends on the patient's actual glucose status and clinical condition," the notice says.

Nova Biomedical stated that the issue does not affect the analytical performance of the glucose measurements themselves, according to the notice.

Only the Gen 2.0 model

The removal applies only to the most recent model of the system, the "Gen 2.0," on all firmware versions, and not to previously released models such as the "Gen 1.86," the FDA said. The FDA's recall page lists the StatStrip Glucose Hospital Meter System, model 63685, and the Glucose Hospital Meter System Multipack, model 66739.

As of October 5, 2026, Nova Biomedical had reported one serious injury and no deaths associated with the issue, according to the FDA.

An earlier software correction

It is not the first time a StatStrip software issue has drawn the FDA's most serious recall classification. In a separate action, Nova sent an urgent field correction notice in November 2024, revised in December 2024, for StatStrip hospital meters running certain software versions, after a defect could cause meters to transmit incorrect glucose or ketone results to hospital record systems when an operator reviewed historical results during transmission. That action involved correcting devices rather than removing them, and the FDA page reported no injuries or deaths.

Next steps

The FDA describes the action as a recall that "involves removing certain devices from where they are used or sold." Its October 20 notice did not give a date for the software update that Nova's letter refers to, and it did not say how many meters are affected. US customers with adverse reactions, quality problems or questions about the recall are directed to contact Nova Biomedical, and the FDA asks health care professionals to report problems through its MedWatch program.