Recall Z-0681-2025
Nova Biomedical Corporation · initiated November 20, 2024
Class I – dangerous or defective products that could cause serious health problems or death
Product
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
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.
FDA-determined cause: Software design
Action taken
Nova Biomedical notified consignees via letter on 11/20/2024. Consignees were instructed that all current Nova StatStrip customers that have gone Live with their new meters recently received a meter software update (v.0.0.13.45 or above) from Nova Biomedical to eliminate the potential risk described above. All remaining customers that have been shipped StatStrip meters impacted by this field correction, will have their meter software updated by Nova Biomedical or local dealer prior to going "Live" with their new meters.
Details
- Recall number
- Z-0681-2025
- Initiated
- November 20, 2024
- Posted by FDA
- December 20, 2024
- Product code
- PZI – Prescription Use Blood Glucose Meter For Near-Patient Testing
- Quantity
- 2,365 units
- Distribution
- Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
- Recalling firm
- Nova Biomedical Corporation, Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0682-2025 Class I | StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683.…A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient… | 11/20/2024Open, Classified |
| Z-0683-2025 Class I | StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910.…A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient… | 11/20/2024Open, Classified |