STATSTRIP recallZ-3128-2026 · Nova Biomedical Corporation · initiated Jul 29, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nova Biomedical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software design
What the company is doing
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- [email protected]; European Union- [email protected] and all other international [email protected]. 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.
Recall details
- Recall number
- Z-3128-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 29, 2026
- Posted by the FDA
- Sep 11, 2026
- Recalling firm
- Nova Biomedical Corporation
- Quantity
- 20,616 units
- Product code
- PZI
- FDA submissions
- K232075
- 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.
Product description
StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
Code information (models, lots, serial numbers)
Model No: 63685. UDI-DI: 00385480636858. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- StatStrip 63685Nova Biomedical Corporation · Prescription use blood glucose meter for near-patient testing1 recall3 deaths33 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99546).
- Z-3129-2026 · Open, ClassifiedStatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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