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# Nova Bio Recalls Glucose Meters
- URL: https://www.fdaweb.com/nova-bio-recalls-glucose-meters/
- Published: 2025-01-30T12:00:00.000Z
- Updated: 2026-09-14T14:52:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158573

Nova Biomedical is recalling (Class 1 device correction) its StatStrip Glucose and Glucose/Ketone Hospital Meters due to the potential risk that a software error may cause incorrect glucose or ketone patient test results to be transmitted to hospital medical record systems. “The issue occurs when an operator visits the ‘Review Results’ screen to review previous historical test results while the meter is still in the process of transmitting current results wirelessly to the system,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/glucose-and-glucoseketone-meter-correction-nova-biomedical-corporation-issues-software-correction?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. “The issue may affect all historical test results within the system before the meters are updated to v.0.0.13.45 software.”

The notice says that using affected products may cause serious adverse health consequences due to treatment decisions that can be made based on incorrect blood glucose or ketone levels, which can result in low blood sugar, high blood sugar, or high levels of ketones in the blood. “This risk of serious adverse health consequence is elevated in a subset of the intended use population, which includes neonates and patients receiving intensive medical care,” it says. To date, no injuries have been reported that are related to the issue.

The devices are used in hospitals and health care settings to measure glucose in a patient’s blood. It measures glucose in samples collected from a finger stick, a blood vessel, or a newborn’s heel stick, the notice says.