Device recall
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
- Recall number
- Z-3131-2026
- Event id
- 99546
- Status
- Ongoing
- FDA classification
- Class I
- Recalling firm
- Nova Biomedical Corporation
- Report date
- Sep 23, 2026
- Posted
- Sep 11, 2026
- Initiated
- Jul 29, 2026
- Center classification date
- Sep 11, 2026
- Product code
- PZI
- Device type
- Prescription Use Blood Glucose Meter For Near-Patient Testing
- 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 to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.
- Root cause
- Software design
- Quantity
- 8,939 units
- Code info
- Model No: 63910. UDI-DI: 00385480639101. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Waltham, MA, United States