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

FDA device recall Z-0681-2025 · posted 2024-12-20 · Open, Classified

Recall details

Recalling firm

Nova Biomedical Corporation

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.

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

PZI

Quantity affected

2,365 units

Distribution

Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.

Date initiated

2024-11-20

Date posted

2024-12-20

Location

Waltham, MA

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