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Nova Biomedical has advised customers to remove affected StatStrip Glucose Hospital Meter System Gen 2.0 devices from use or sale while a software update is developed. The FDA says the issue can leave prior patient or quality-control information on screen, risking assignment of a glucose result to the wrong record. As of October 5, the company had reported one serious injury and no deaths.
Nova Biomedical has advised hospitals to remove affected StatStrip Glucose Hospital Meter System Gen 2.0 devices from use or sale until a software update is available, after reports that the meters can retain earlier patient or quality-control information during barcode scanning. The FDA identifies the recall as its most serious type and warns that a result assigned to the wrong patient record could affect treatment decisions.
The issue applies to the Gen 2.0 model only, including the StatStrip Glucose Hospital Meter System, model number 636850, and the Glucose Hospital Meter System Multipack, model number 667390. The FDA says the recall does not apply to earlier models, including Gen 1.86. Nova reported that the issue affects Gen 2.0 meters running all versions of firmware.
According to the FDA notice, customers reported that after scanning a patient ID or quality-control barcode, previous information may remain on the meter screen. If that information is accepted, a glucose result could be linked to the wrong patient’s medical record or the wrong quality-control ID. Nova said the problem does not affect the analytical performance of glucose measurements; the concern is whether results are associated with the correct patient or QC record.
Nova sent an initial customer letter on July 31 and an updated letter on October 5. For facilities still using an affected meter because no alternative is available, the FDA lists interim steps: use patient-ID validation in NovaNet where the facility’s system supports integrated admission, discharge and transfer data; set the meter to log operators out after each test; and check the displayed patient information both after scanning and again when the result appears. Any result assigned to the wrong record should be reported promptly and corrected under the facility’s established procedures.
Wrong-Patient Results Can Affect Care
The concern is not that the meter’s glucose measurement is inaccurate, according to Nova, but that a measured result could be attached to another patient’s record. Clinicians may then act on a result that does not belong to the person being treated, or miss information needed for that person’s care.
The FDA says possible consequences include delayed treatment, unnecessary treatment—including inappropriate insulin administration—or failure to treat the intended patient. The notice says harm depends on the patient’s actual glucose status and clinical condition. It identifies critically ill patients and infants as being at greater risk, including because infants may be unable to communicate symptoms of low blood sugar.
As of October 5, Nova had reported one serious injury and no deaths associated with the issue. That count is the company’s reported status in the FDA notice; it does not establish how often the device behavior occurs or how many patients may have been affected.
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Scope of the Gen 2.0 Recall
The StatStrip hospital meter is a hand-held, battery-powered diagnostic instrument used with Nova Biomedical glucose test strips to measure glucose in whole blood. It also stores patient-test and quality-control data, along with information about the patient, sample, operator, reagents and meter. Correctly linking that stored information to the right patient is central to the recall concern.
The FDA describes this action as a removal recall: affected devices are to be taken out of places where they are used or sold. Nova has also placed a shipment hold on new Gen 2.0 systems while it develops and validates corrective actions. The agency’s notice distinguishes this model from earlier StatStrip systems, so the recall should not be read as applying to every StatStrip meter.
Frequency and Patient Impact
The FDA notice does not state how many devices or facilities are affected, how often prior information remains on screen, or whether the reported serious injury resulted from a specific treatment decision. It also does not identify the patient or describe the circumstances of that injury.
The company’s statement that glucose measurement performance is unaffected does not resolve whether a particular result was correctly associated with a patient record. The notice does not provide details about the software fix’s technical design or report that the update has completed validation. The extent of any additional patient impact remains unclear.
Software Validation and Rollout
Nova is developing and validating a software update and, according to the FDA notice, intends to begin a phased rollout in November 2026. The update is expected to include measures addressing the recall issue as well as other improvements that the notice describes as non-safety-related. The company has not provided further rollout details in the supplied notice.
Until the update is available, facilities should follow Nova’s customer instructions and the FDA-listed mitigation steps. Where an alternative device is available, the notice says users should stop using the affected meter. If a facility has no alternative, it should continue the mitigation measures, check patient identifiers at both stages of testing, and promptly flag or correct any result found in the wrong medical record.
Key Questions
Which glucose meters are affected?
The recall applies to the StatStrip Glucose Hospital Meter System Gen 2.0, including models 636850 and 667390. The FDA says Gen 1.86 and other previously released models are not included in this action.
Why are the Gen 2.0 meters being removed?
Customers reported that old patient or quality-control information may remain on screen after a barcode scan. If accepted, a glucose result could be associated with the wrong patient record or QC ID.
Does the recall mean the glucose readings are inaccurate?
Nova told the FDA that the issue does not affect the analytical performance of glucose measurements. The reported concern is the possible assignment of a result to the wrong patient or quality-control record.
What should hospitals do before the update is available?
Facilities with an alternative device should stop using affected meters. If no alternative is available, the FDA notice advises following Nova’s mitigation steps, including checking the patient ID after scanning and again when the result appears, and promptly addressing any result linked to the wrong record.
When is the software update expected?
Nova intends a phased rollout in November 2026, according to the FDA notice. The update was still being verified and validated in the information provided.
Source: primary
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