Urgent Field Safety Notice For Statstrip (gen 2) Glucose And Glucose/ß-ketone Hospital Meter Systems By Nova Biomedical

Summary Nova Biomedical is issuing an urgent safety notice for StatStrip (Gen 2) Glucose and Glucose/ß-Ketone Hospital Meter Systems distributed in Germany and the EU. The notice indicates a Class I safety issue with these hospital blood glucose testing devices. This affects healthcare facilities in Germany and EU countries that use these particular meter systems.

Recalling firm
Nova Biomedical
Product
StatStrip (Gen 2) Glucose and Glucose/ß-Ketone Hospital Meter Systems
Reason
Urgent Field Safety Notice for StatStrip (Gen 2) Glucose and Glucose/ß-Ketone Hospital Meter Systems by Nova Biomedical
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-08-19
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/00b2c197-d91f-4bb6-8663-6166dabe2e72