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Jump to Key Points Nova Biomedical has recalled its StatStrip Glucose Hospital Meters pending a software update to fix a problem that could lead to mixing up glucose values between patients.
The FDA issued a notice about the recall on October 20, 2026, saying that Nova has advised customers to remove all StatStrip "Gen 2.0" meters from where they are used or sold until a software update becomes available.
The defect does not affect the devices' glucose measurements. Rather, when the patient identification or quality control barcodes are scanned, the screen may reflect information from a previous reading, potentially leading to a glucose result being assigned to the wrong patient. This could lead to serious harm if clinical decisions for one patient are based on readings from another, including delayed or unnecessary treatment such as inappropriate insulin administration.
"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," the FDA said in its statement.
- StatStrip Gen 2.0 recalled; barcode scan defect may misassign glucose values.
- Glucose assay unaffected; error occurs during patient/QC barcode display.
- Wrong-patient assignment may trigger inappropriate insulin or delayed treatment.
- Critically ill patients and infants at ↑ risk for harm from misassigned results.
- One serious injury reported; no deaths; shipments held pending software update.
The Gen 2.0 is the most recent version of the handheld, battery-powered in vitro diagnostic laboratory instrument that works in conjunction with Nova's compatible test strips to measure glucose in whole blood or in a quality control solution. The recall does not apply to prior models such as the "Gen 1.86."
The company sent affected customers an initial letter regarding the issue on July 31, 2026. Then on October 5, they sent an updated letter with specific recommendations for configuring electronic health records to ensure validation of individual patient identification for each glucose scan, and for flagging/removing wrongly assigned glucose values.
As of October 5, Nova Biomedical has reported one serious injury and no deaths associated with this issue.
Nova Biomedical has now held shipments of all Gen 2.0 StatStrip Glucose Hospital Meter Systems pending development and validation of a software update to fix the problem. The company intends to begin rolling out these updates in November 2026, along with other non-safety-related improvements.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR's Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker and Bluesky @miriametucker.bsky.social
