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Hospital Glucose Meter Recall: Nova Biomedical Removes StatStrip Glucose Hospital Meter Systems
The FDA 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. This removal only applies to the most recent model of the StatStrip Glucose Hospital Monitoring System, the “Gen 2.0” model, and does NOT apply to any previously released model of the StatStrip Glucose Hospital Meter System such as the “Gen 1.86”.
Nova Biomedical stated the issue affects StatStrip Glucose Hospital Meter Systems (Gen 2.0) operating on all versions of firmware and does not impact the analytical performance of glucose measurements.
Nova Biomedical has received reports from customers indicating that when scanning patient ID or Quality Control (QC) barcodes, prior information may remain on the meter screen, which if accepted, will lead to a glucose result being assigned to the wrong patient’s medical record or QC ID. 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 severity of harm depends on the patient’s actual glucose status and clinical condition. Critically ill patients and infants, who may be unable to communicate symptoms of hypoglycemia, are at greater risk of adverse outcomes.
As of October 5, 2026 Nova Biomedical has reported one serious injury and no deaths associated with this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Nova Biomedical at 1(800) 545-6682.
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