PZIClass II

Prescription Use Blood Glucose Meter For Near-patient Testing

Clinical Chemistry · 21 CFR 862.1345

Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.

MDR events139All time

Recalls1All time

Registered firms20Currently listed

510(k) clearances14All time

Recent MDR events

139 adverse event reports on file

Event type breakdown

Malfunction132

Injury4

Death3

Most-reported manufacturers

Nova Biomedical Corp.69 Roche Diagnostics24 Nova Biomedical Corp23 Nova Biomedical Corporation17 Nova Biomedical Corp.2 Unspecified1 Nova Bioemdical Corp1 Nova Biomedical Corporation Diabetes Products1

Recalls

1 recall events for this product code

Nova Biomedical Corporation
Open, ClassifiedDec 20, 2024
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
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.
Z-0681-2025 · View FDA record ↗

Registered firms

20 firms currently registered for this product code

510(k) clearances

14 clearances for this product code