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Class IOngoing

Nova Biomedical Corporation recalls 5 products

Recall date · record updated Sep 23, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Nova Biomedical Corporation
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.
Hazard
FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99546…

Products (5)

  1. 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 unitsRecall no. Z-3128-2026Class I

  2. 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 unitsRecall no. Z-3129-2026Class I

  3. 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 unitsRecall no. Z-3130-2026Class I

  4. 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 unitsRecall no. Z-3131-2026Class I

  5. 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 unitsRecall no. Z-3132-2026Class I

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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