StatStrip Glucose Hospital Meter System. Model/Catalog… recallZ-0681-2025 · Nova Biomedical Corporation · initiated Nov 20, 2024
Class I Open, Classified All recalls posted in December 2024
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 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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0681-2025
- Recall class
- Class I (most serious)
- Status
- Open, Classified
- Initiated by the company
- Nov 20, 2024
- Posted by the FDA
- Dec 20, 2024
- Recalling firm
- Nova Biomedical Corporation
- Quantity
- 2,365 units
- Product code
- PZI
- FDA submissions
- K232075
- Distribution
- Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
Product description
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Code information (models, lots, serial numbers)
Model No 63685. UDI-DI (01)10385480636858. Software Versions: v0.0.13.10 to v0.0.13.44
Other devices under the same FDA submission
1 device cleared under K232075 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- StatStrip 63685Nova Biomedical Corporation · Prescription use blood glucose meter for near-patient testing1 recall3 deaths33 reports
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 18, 2026. Text above is shown as published by the FDA.
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