Nova Biomedical StatStrip ketone test strips
Device Safety Information: Nova Biomedical StatStrip ketone test strips: risk of disruption to blood ketone testing due to quality-control failures and supply interruption.
Published: 19 October 2026
The Medicines and Healthcare products Regulatory Agency (DHSC) published Device Safety Information regarding quality issues affecting specified lots of StatStrip ketone test strips. A National Patient Safety Alert was also published which included actions to be completed by providers.
The Device Safety Information (DSI) and the Field Safety Notice (FSN) have been updated to include an additional batch number.
The Device Safety Information has further information and the additional batch number.