Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0683-2025 — StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing

U.S. FDA — Device Enforcement · United States · 2024-11-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0683-2025
Date of alert
2024-11-20
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Nova Biomedical Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
1038548063910
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.