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U.S. Department of Health and Human Services

Class 1 Device Recall StatStrip Glucose Ketone Hospital Meter System

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 Class 1 Device Recall StatStrip Glucose Ketone Hospital Meter Systemsee related information
Date Initiated by FirmNovember 20, 2024
Date PostedDecember 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0682-2025
Recall Event ID 95783
Product Classification unknown device name - Product Code N/A
ProductStatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Code Information Model No 63683. UDI-DI (01)38548063685. Software versions: v0.0.13.10 to v0.0.13.44.
Recalling Firm/
Manufacturer		 Nova Biomedical Corporation
200 Prospect St
Waltham MA 02453-3407
For Additional Information ContactRebecca Figueira
781-647-3700 Ext. 3638
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionNova Biomedical notified consignees via letter on 11/20/2024. Consignees were instructed that all current Nova StatStrip customers that have gone Live with their new meters recently received a meter software update (v.0.0.13.45 or above) from Nova Biomedical to eliminate the potential risk described above. All remaining customers that have been shipped StatStrip meters impacted by this field correction, will have their meter software updated by Nova Biomedical or local dealer prior to going "Live" with their new meters.
Quantity in Commerce347 units
DistributionDistribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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