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U.S. Department of Health and Human Services

Class 1 Device Recall StatStrip Glucose Hospital Meter System

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 Class 1 Device Recall StatStrip Glucose Hospital Meter Systemsee related information
Date Initiated by FirmNovember 20, 2024
Date PostedDecember 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0681-2025
Recall Event ID 95783
510(K)NumberK232075 
Product Classification Prescription use blood glucose meter for near-patient testing - Product Code PZI
ProductStatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Code Information Model No 63685. UDI-DI (01)10385480636858. 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 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.
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 Commerce2,365 units
DistributionDistribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = PZI
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