Nova Biomedical Corporation: Medical Device Recall in 2025 - (Recall #: Z-0683-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing

Product Classification:

Class I

Date Initiated: November 20, 2024

Date Posted: January 1, 2025

Recall Number: Z-0683-2025

Event ID: 95783

Reason for Recall:

A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone 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 test result to the DMS.

Status: Ongoing

Product Quantity: 1,615 units

Code Information:

Model No 63910. UDI-DI (01)1038548063910. Software Versions: v0.0.13.10 to v0.0.13.44.

Distribution Pattern:

Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated