Recall Z-0681-2025 ยท PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
Nova Biomedical Corporation
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
| Date | Dec 20, 2024 (initiated Nov 20, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 2,365 units |
| Distribution | Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232075 | StatStrip Glucose Hospital Meter System Nova Biomedical Corporation, Feb 23, 2024 |