Recall Z-3132-2026 ยท PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
Nova Biomedical Corporation
StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
| Date | Sep 11, 2026 (initiated Jul 29, 2026) |
| Status | Open, Classified |
| 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 |
| Root cause | Software design |
| Action | Nova Biomedical issued an "URGENT MEDICAL DEVICE RECALL" Customer Advisor Notice to its consignees on 7/29/2026 via email. The notice explained the issue, potential risk, and requested consignees follow the below specific recommendations until a permanent resolution can be provided. 1. Verifying patient information displayed on the meter exactly matches the scanned patient identification after every patient barcode scan and before accepting the patient's record or result. 2. If the displayed patient information does not match the scanned patient identification, discontinue testing with the |
| Quantity | 2,044 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.