Healthcare services alerted to ketone testing disruption
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Device Safety Information notice concerning Nova Biomedical StatStrip ketone test strips, following reports of quality-control failures and supply interruptions.
The disruption, which is primarily affecting healthcare services in England, has prompted a coordinated national response involving the Department of Health and Social Care, NHS England and relevant healthcare services.
Blood ketone testing plays an important role in identifying and monitoring diabetic ketoacidosis (DKA), a potentially life-threatening complication of diabetes. Disruption to testing supplies could therefore affect services that rely on rapid blood ketone measurements.
Advice for healthcare professionals
The MHRA has published information identifying affected products and setting out actions for healthcare providers, including measures relating to affected stock and alternative testing arrangements.
A National Patient Safety Alert has also been issued, outlining actions for affected healthcare providers to manage the disruption and maintain safe testing arrangements.
Biomedical scientists and other healthcare professionals involved in point-of-care testing, laboratory services and clinical governance should review the published safety notices and ensure that appropriate local arrangements are in place.
NHS England has also published interim clinical prioritisation guidance for blood ketone testing during the supply disruption. Services should also follow this guidanc, alongside any relevant national and local instructions.
The IBMS will continue to share relevant information as further official guidance becomes available.
Further information
- MHRA Device Safety Information: Nova Biomedical StatStrip ketone test strips (DSI/2026/013)
- MHRA Field Safety Notices for October 2026
- National Patient Safety Alert: Supply disruption for Nova Biomedical StatStrip blood ketone test strips
- NHS England: Interim clinical prioritisation guidance for blood ketone testing during supply disruption