BEUDAMED
    FDA Enforcement Class I Ongoing

    StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.

    Recall: Z-0681-2025 · Reported January 1, 2025

    Enforcement

    Recall Number
    Z-0681-2025
    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 Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.

    Reason

    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.

    Code Info

    Model No 63685. UDI-DI (01)10385480636858. 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

    2,365 units