Official recall record
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-11-20
- Country of alert
- United States
- Alert level
- Class I
- Alert type
- recall
- Brand on record
- Nova Biomedical Corporation
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-07-29 · US FDA — Medical Devices
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. - 2026-07-29 · US FDA — Medical Devices
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. - 2026-07-29 · US FDA — Medical Devices
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.