Class 1 Device Recall StatStrip Glucose Hospital Meter System

• Date Initiated by Firm: July 29, 2026
• Date Posted: September 11, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3128-2026
• Recall Event ID: 99546
• 510(K)Number: K232075
• Product Classification: Prescription use blood glucose meter for near-patient testing - Product Code PZI
• Product: StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
• Code Information: Model No: 63685. UDI-DI: 00385480636858. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
• FEI Number: 1219029
• Recalling Firm/ Manufacturer: Nova Biomedical Corporation; 200 Prospect St; Waltham MA 02453-3407
• For Additional Information Contact: Mariya Cesnulevicius; 781-647-3700 Ext. 1233
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 meter and notify your administrator. 3. Nova recommends that a copy of this notice is provided to all end users within your facilities that use the StatStrip (Gen 2) Glucose Hospital Meter Systems for patient testing and care. Additionally, Nova recommends placing a copy of this notice in all areas where the meters are stored and used. 4. Complete and return the acknowledgement form to appropriate emails: North America- Novameters@novabio.com; European Union- EU-QA@novabio.com and all other international customers-Intlservice@novabio.com. Nova is actively working on a planned firmware update to address this issue. As a precautionary measure, Nova has implemented a shipment hold on all StatStrip (Gen 2) Glucose Hospital Meter Systems while corrective actions are being developed and validated. Efforts are underway for the development and validation of the firmware update to address this issue. Nova will communicate availability as soon as validation activities are completed targeting September 2026. If you have questions regarding this notice, please contact Nova Biomedical Technical Support at 1 (800) 545-6682 (USA) or at (800) 263-5999 (Canada). Nova Biomedical Technical Support can be reached 24 hours a day, 7 days a week, 365 days a year. For customers outside of the USA or Canada, please contact your authorized Nova Biomedical distributor.
• Quantity in Commerce: 20,616 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PZI