MHRA: Nova Biomedical Recalls Ketone Test Strips Over Quality Failures

We use some essential cookies to make this website work. We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. We also use cookies set by other sites to help us deliver content from their services. You have accepted additional cookies. You can change your cookie settings at any time. You have rejected additional cookies. You can change your cookie settings at any time. Nova Biomedical has identified quality issues affecting specified lots of StatStrip ketone test strips. The affected lots have been associated with quality-control (QC) failures and Nova Biomedical has initiated a recall, advising that these lots should not be used. Nova Biomedical has identified quality issues affecting specified lots of StatStrip ketone test strips. The affected lots have been associated with quality-control (QC) failures and Nova Biomedical has initiated a recall, advising that these lots should not be used. Nova Biomedical has also paused distribution of the affected lots and advised that any further lots found to fail QC testing should also be withdrawn from use. The recall, paused distribution and potential withdrawal of additional lots may result in a progressive reduction in the availability of ketone test strips and disruption to blood ketone point-of-care testing. Nova Biomedical has advised that replacement stock is not expected to be available in the UK for approximately 4 weeks, which may increase the risk of supply constraints during this period. Nova Biomedical has identified quality issues affecting specified lots of StatStrip ketone test strips. The affected lots have been associated with repeated quality-control (QC) failures. Nova Biomedical has initiated a recall of specified lots and has advised that these lots should not be used. Nova Biomedical has also placed affected lots on stop-ship and advised that additional lots should be withdrawn from use if they subsequently fail QC testing. This creates the potential for a progressive reduction in the quantity of strips available for clinical use. The resulting supply disruption may significantly reduce the availability of blood ketone point-of-care testing across the NHS. Nova Biomedical has advised that it is unable to replenish UK stock levels for approximately 4 weeks. Blood ketone testing is an important diagnostic and monitoring method used in patients at risk of, or with suspected or established, diabetic ketoacidosis (DKA). It is used across emergency departments, acute inpatient services, paediatric services, ambulance and paramedic services, community hospitals, urgent community response, virtual wards, hospital-at-home services, primary care and district/community nursing. The NHS advises that blood ketone concentrations above 3 mmol/L may indicate DKA and require emergency assessment. NICE incorporates blood ketone measurement into the diagnostic and monitoring pathways for DKA. In children and young people, NICE recommends measurement of blood ketones using a near-patient method when DKA is suspected. Where a near-patient blood ketone method is not available, NICE recommends immediate transfer to a hospital with acute paediatric facilities. The clinical risk associated with loss of timely blood ketone testing is greatest where a patient is acutely unwell, DKA is suspected or being treated, and an alternative validated method of obtaining a clinically appropriate ketone result is not immediately available. Loss of testing capacity may result in delayed recognition or assessment of DKA, delayed escalation or hospital transfer, delayed treatment decisions, or impaired monitoring of response to treatment. DKA is a potentially life-threatening condition, and such delays may contribute to severe clinical deterioration, critical illness, permanent harm or death. The Department of Health and Social Care will be issuing clinical guidance on this. Organisations should consider the impact of reduced blood