Nova Biomedical Corporation medical device recall: StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose…

Reason for recall

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.

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Jul 29, 2026. FDA classified it 44 days later, on Sep 11, 2026. This recall event covers 5 separate products, each with its own FDA recall number. Distribution reported by FDA: 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. Nova Biomedical Corporation has 7 recalls in our records.

Recalled products (5)

• Z-3128-2026 Class I Ongoing

  StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.

  Codes / lots: Model No: 63685. UDI-DI: 00385480636858. Software Versions: All versions 0.00.13.10 through 1.5.14.25.

  Quantity: 20,616 units

• Z-3129-2026 Class I Ongoing

  StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.

  Codes / lots: Model No: 66739. UDI-DI: 0038548063685. Software Versions: All versions 0.00.13.10 through 1.5.14.25.

  Quantity: 10,941 units

• Z-3130-2026 Class I Ongoing

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

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

  Quantity: 1,858 units

• Z-3131-2026 Class I Ongoing

  StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.

  Codes / lots: Model No: 63910. UDI-DI: 00385480639101. Software Versions: All versions 0.00.13.10 through 1.5.14.25.

  Quantity: 8,939 units

• Z-3132-2026 Class I Ongoing

  StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.

  Codes / lots: Model No: 66429. UDI-DI: :00385480664295. Software Versions: All versions 0.00.13.10 through 1.5.14.25.

  Quantity: 2,044 units