Recall Atlas

Nova Biomedical recalls

4 official recalls and safety alerts involving Nova Biomedical since 2023-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Nova Biomedical or the relevant agency.

  1. 2026-09-23
  2. US
    Drugs & medicalClass I

    Nova Biomedical Corporation recalls StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.

    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)…

    FDA · DeviceNova Biomedical CorporationWorldwide distribution: US (nationwide) and OUS (foreign) countries of:…Official notice →
  3. 2025-01-01
  4. US
    Drugs & medicalClass I

    Nova Biomedical Corporation recalls StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for…

    A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user…

    FDA · DeviceNova Biomedical CorporationDistribution US Nationwide including Puerto Rico, Germany, Italy, Israel,…Official notice →
  5. US
    Drugs & medicalClass I

    Nova Biomedical Corporation recalls StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.

    A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using…

    FDA · DeviceNova Biomedical CorporationDistribution US Nationwide including Puerto Rico, Germany, Italy, Israel,…Official notice →
  6. 2023-11-08
  7. US
    Drugs & medicalClass II

    Nova Biomedical Corporation recalls Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and…

    Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge…

    FDA · DeviceNova Biomedical CorporationNationwide Foreign: Country Algeria Australia Austria Bangladesh Benin Bolivia…Official notice →