Recall Z-0681-2025— Nova Biomedical Corporation

Name: FDA recall Z-0681-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-20

Class I · Ongoing

Class I FDA medical device recall by Nova Biomedical Corporation, initiated 2024-11-20. It names one FDA 510(k) clearance: K232075. Product: 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..

Recalling firm: Nova Biomedical Corporation
Classification: Class I
Status: Ongoing
Initiated: 2024-11-20
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K232075 — StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation·cleared 2024-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.