BEUDAMED
    FDA Enforcement Class I Ongoing

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

    Recall: Z-0683-2025 · Reported January 1, 2025

    Enforcement

    Recall Number
    Z-0683-2025
    Event ID
    95783
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nova Biomedical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 1, 2025
    Initiation Date
    November 20, 2024
    Classification Date
    December 20, 2024
    Address
    200 Prospect St, Waltham, MA, 02453-3407, United States

    Description

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

    Reason

    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.

    Code Info

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

    Distribution

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

    Quantity

    1,615 units