Z-0681-2025Class I

StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter...

Name: Z-0681-2025 StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter...
Creator: Nova Biomedical Corporation
Published: 2024-11-20
License: https://open.fda.gov/license/

Nova Biomedical Corporation / initiated 2024-11-20 / Open, Classified / root cause: software

FDA source

Nova Biomedical Corporation began a recall of StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing on 2024-11-20. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0681-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-11-20
Posted: 2024-12-20
Recalling firm: Nova Biomedical Corporation
Product: StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Product code: PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
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.
Root cause tag: software
FDA root cause: Software design
Action: Nova 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 commerce: 2,365 units
Distribution: Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
Product codes and lots: Model No 63685. UDI-DI (01)10385480636858. Software Versions: v0.0.13.10 to v0.0.13.44

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0681-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0681-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0682-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0683-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20

Product code PZI

K232075Class IIStatStrip Glucose Hospital Meter SystemNova Biomedical Corporation / cleared 2024-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)