Reported Jan 1, 2025 · Ongoing
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone…
Nova Biomedical Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nova Biomedical Corporation · 200 Prospect St · Waltham, MA · 02453-3407
Is this the product you have?
- StatStrip Glucose Ketone Hospital Meter System
- Model/Catalog Number63683. Prescription use blood glucose ketone meter for near-patient testing
- Lot codes and dates
- Model No 63683. UDI-DI (01)38548063685
- Software versionsv0.0.13.10 to v0.0.13.44
- Amount recalled
- 347 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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