Nova Biomedical Corporation medical device recall: StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685.…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 95783
- Recall initiated
- Nov 20, 2024
- Classified by FDA
- Dec 20, 2024
- Posted in Enforcement Report
- Jan 1, 2025
- Recalling firm
- Nova Biomedical Corporation
- Firm location
- Waltham, MA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
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 WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
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 navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
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 Nov 20, 2024. FDA classified it 30 days later, on Dec 20, 2024. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands. Nova Biomedical Corporation has 7 recalls in our records.
Recalled products (3)
Z-0681-2025 Class I Ongoing
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Codes / lots: Model No 63685. UDI-DI (01)10385480636858. Software Versions: v0.0.13.10 to v0.0.13.44
Quantity: 2,365 units
Z-0682-2025 Class I Ongoing
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Codes / lots: Model No 63683. UDI-DI (01)38548063685. Software versions: v0.0.13.10 to v0.0.13.44.
Quantity: 347 units
Z-0683-2025 Class I Ongoing
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
Codes / lots: Model No 63910. UDI-DI (01)1038548063910. Software Versions: v0.0.13.10 to v0.0.13.44.
Quantity: 1,615 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 95783
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.