BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0681-2025 · Initiated November 20, 2024

    Recall

    Recall Number
    Z-0681-2025
    Event Number
    95783
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    PZI
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    November 20, 2024
    Posted
    December 20, 2024
    Address
    200 Prospect St, Waltham, MA, 02453-3407

    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.

    Action

    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.

    Distribution

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

    Quantity

    2,365 units