StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter
Summary
The FDA issued a Class I for StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Pre by Nova Biomedical Corporation. Reason: A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's d.
Details
Source
Device Recall
External ID
Z-0682-2025
Action Date
2025-01-01
Status
Ongoing
Category
device
Product Description
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Lot/Code Info: Model No 63683. UDI-DI (01)38548063685. Software versions: v0.0.13.10 to v0.0.13.44.
Quantity Affected: 347 units
Reason for Recall
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.
Distribution
Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-20
Company
Waltham, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Nova Biomedical Corporation has 12 FDA actions in our database, including 5 recalls and 7 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nova Biomedical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nova Biomedical Corporation have FDA actions?
Nova Biomedical Corporation has 12 FDA actions in our database, including 5 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0682-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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