Nova Biomedical Corporation recalls StatStrip Glucose and B- Ketone meter.

Recalling company

Nova Biomedical Corporation

Product

StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.

Reason

A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Jul 29, 2026

Reported

Sep 23, 2026

Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.

Status

Ongoing

Quantity

1,858 units

Lot / codes

Model No: 63683. UDI-DI: 00385480636834. Software Versions: All versions 0.00.13.10 through 1.5.14.25.

Company location

Waltham, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-3130-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3130-2026 in the FDA Enforcement Report. Also see FDA recall press releases.