National Patient Safety Alert: StatStrip® beta-ketone testing strips (Nova Biomedical)

National Patient Safety Alert:

• StatStrip® beta-ketone testing strips (Nova Biomedical)

National Patient Safety Alert Reference Number: NatPSA/2026/007/NSDR

Date issued: 13 October 2026

Explanation of identified safety issue

Nova 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 has initiated a recall, advising that these lots should not be used. Lot numbers can be found on Nova’s Field Safety Notice. Nova has paused distribution of affected lots and advised that any further lots found to fail QC testing should also be withdrawn from use. This may result in further disruption to blood ketone point-of-care testing. Nova currently expects new product to be available for shipment to the UK during the week of 26 October 2026.

Blood ketone testing is an important diagnostic and monitoring method used in patients at risk of, or with suspected or established, diabetic ketoacidosis (DKA), euglycaemic DKA and other clinically significant ketonaemia. 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, mental health services, primary care and district/community nursing.

Without blood ketone tests patients may come to harm or be exposed to potential harm. 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 for clinically appropriate ketone testing 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.

Interim clinical prioritisation guidance has been published by NHS England to support clinical decision-making regarding use of available blood ketone test strips whilst maintaining rapid recognition and safe management of diabetic ketoacidosis (DKA), euglycaemic DKA and other clinically significant ketonaemia.

Actions required

Actions to be completed by 20/10/2026

Organisations should identify a clinical lead and form a working group to act on the Field Safety Notice issued by Nova and follow the advice issued by MHRA in their Device Safety Notice.

This will include taking action to:

1. Discontinue clinical use and dispose of all lots identified by Nova as subject to recall.
2. Assess current and anticipated blood ketone testing capacity, including the number and location of ketone testing devices, current usable strip stock and anticipated out-of-stock dates.
3. Identify and validate alternative ketone testing methods where available, including alternative point-ofcare devices and laboratory testing.
4. Prioritise available blood ketone testing for patients at greatest clinical risk where supply is constrained.

Please see full guidance in the alert.