Device safety informationMHRA
Nova Biomedical StatStrip ketone test strips safety warning over inaccurate results
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.
What to do now
Nova Biomedical StatStrip ketone test strips may give inaccurate test results.
- Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
- Check the model, lot or serial number against the details on this page.
- Any incident involving the device can be reported through the Yellow Card scheme.
Why it matters. An inaccurate result can lead to the wrong treatment decision, so affected kits or strips should not be relied on.
Replacements and support
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.
Do not throw away a device you rely on until a replacement has been arranged.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2026/013). Quoted as issued.
Summary
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.
The risk
Post Publication Note - 16 October 2026 The Device Safety Information (DSI) and the Field Safety Notice (FSN) have been updated to include an additional batch number. Summary
Advice for healthcare professionals
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also paused distribution of the affected lots and advised that any further lots found to fail QC testing should also be withdrawn from use.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.
if your organisation uses Nova Biomedical StatStrips, establish which lots are currently held and available for clinical use
discontinue clinical use and dispose of all lots identified by Nova Biomedical as subject to recall
for lots that are not subject to recall, ensure users follow the instructions for use. If a lot fails QC testing on two consecutive occasions, remove the lot from use, dispose of any remaining test strips in accordance with local procedures, and switch to an alternative lot number if available, or use an alternative method for blood ketone testing
do not assume that the current quantity of strips represents the duration of available supply, as additional lots may become unavailable if there is QC failure
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
identify and validate alternative ketone testing methods where available, including alternative point-of-care devices and laboratory testing
where supply is constrained, prioritise available blood ketone testing for patients at greatest clinical risk, including patients with suspected or established Diabetic Ketoacidosis (DKA), paediatric patients, acutely unwell patients with type 1 diabetes and patients requiring serial ketone measurements during DKA treatment
ensure that appropriate escalation arrangements are in place where clinically indicated ketone testing is unavailable
ensure that relevant clinical, point-of-care testing, procurement and governance teams are aware of the supply disruption and appropriate local contingency arrangements are implemented
the advice in this DSI is aimed at healthcare professionals who are managing your care. You can be reassured that your healthcare professional will take the necessary steps to ensure your care is not impacted. If you have any concerns, contact your healthcare professional
Advice for patients
The Device Safety Information (DSI) and the Field Safety Notice (FSN) have been updated to include an additional batch number.
the advice in this DSI is aimed at healthcare professionals who are managing your care. You can be reassured that your healthcare professional will take the necessary steps to ensure your care is not impacted. If you have any concerns, contact your healthcare professional
if you experience vomiting, abdominal pain, deep/rapid breathing, fruity/pear-smelling breath, marked drowsiness or confusion, severe thirst or dehydration, or are becoming progressively unwell, please seek urgent medical care as you may have diabetic ketoacidosis (DKA)
continue following your prescribed sick-day/insulin plan unless your healthcare professional tells you otherwise. Do not stop using your insulin unless your healthcare professional tells you to
keep checking blood glucose frequently if you have a meter or continuous glucose monitor (CGM) and report persistent or worsening high blood glucose levels
Open the MHRA notice
Questions
Why has Nova Biomedical StatStrip ketone test strips been recalled?
Nova Biomedical StatStrip ketone test strips may give inaccurate test results. An inaccurate result can lead to the wrong treatment decision, so affected kits or strips should not be relied on.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.
Who replaces the device?
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.