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Roughly four weeks for new stock: today's alert on the strips used to spot DKA

Qurexa Editorial Team9 October 20269 min read 0 0
Roughly four weeks for new stock: today's alert on the strips used to spot DKA

What happened

On Friday 9 October 2026 the Medicines and Healthcare products Regulatory Agency (MHRA) issued a device safety alert, reference DSI/2026/013. It concerns blood ketone test strips made by Nova Biomedical and sold under the StatStrip name. These are the small strips NHS staff use with a handheld meter to measure ketones in a drop of blood. Some batches failed quality-control testing. Quality control is the routine check staff run to prove a batch is still giving reliable readings. Nova Biomedical has recalled those batches and put them on "stop-ship", meaning it has paused sending them out. The MHRA then adds the part that turns a recall into a supply problem. More batches may fail the same checks and have to be withdrawn too, so usable stock could keep shrinking. Nova Biomedical has told the MHRA that replacement stock is not expected in the UK for roughly four weeks. That points to early November. The alert is addressed to healthcare professionals, healthcare organisations and distributors, not to the public. It notes that blood ketone testing is used across emergency departments, hospital wards, children's services, ambulance services, community hospitals, primary care and community nursing. NHS organisations have been told to work out which batches they hold, stop using and dispose of any batch on the recall list, and remove any batch that fails quality control twice in a row. They must also find and check other ways of testing, including different point-of-care devices and laboratory tests, and keep a written contingency plan until enough reliable testing capacity is confirmed. The Department of Health and Social Care says it will issue clinical guidance. One detail is worth being straight about: the alert does not list the affected batch numbers. It points readers to the manufacturer's own field safety notice instead.

Why this matters

Insulin lets your body use sugar for energy. Without enough insulin, the body burns fat instead, and burning fat makes chemicals called ketones. A few are normal. Too many turn the blood acidic, and that is diabetic ketoacidosis, usually shortened to DKA. DKA is a medical emergency, treated in hospital with insulin and fluids through a drip. The NHS says symptoms usually build over about 24 hours, though they can come on faster. This is where the strips come in. A blood ketone test takes seconds, and the number it gives helps staff answer two urgent questions. Is this DKA? And is the treatment working? The MHRA is blunt about what losing that test could mean. Its alert warns of delay in recognising or treating DKA, delay in moving a patient to the right level of care, and weaker monitoring of how someone responds to treatment. It says this could contribute to severe deterioration, permanent harm or death. That is strong wording from a regulator, and it is why the alert went out publicly. The people most affected are those most likely to need the test: people with type 1 diabetes, children and young people, people with type 2 diabetes who use insulin, and people who have type 1 diabetes without knowing it yet. DKA is a common way type 1 diabetes is first spotted in children. There is also genuine reassurance here. Hospital laboratories can measure blood ketones, and other manufacturers make point-of-care devices. The MHRA has told organisations to check those alternatives and to save the strips they have for the highest-risk patients, naming suspected or confirmed DKA, children, acutely unwell people with type 1 diabetes, and anyone needing repeat tests during DKA treatment. This is a problem the NHS has been told to plan around, not a reason to change what you do at home.

What the evidence actually says

A story like this can be read too hard in either direction, so a few distinctions matter. **This is a quality and supply problem, not a warning that readings in your kitchen are wrong.** The recall covers specific batches used inside NHS services. Nothing in the alert tells anyone at home to throw away a meter or stop testing. **Your own meter is very likely a different product.** Home blood ketone meters in the UK are usually other brands. If you are unsure what you have, your pharmacist or diabetes nurse can tell you in a moment. **Nobody outside the NHS can check a batch number from this alert,** because the numbers are not in it. Matching stock against the recall is a job for hospital procurement and point-of-care testing teams. **No harm has been reported.** The MHRA has not said how many batches are affected, and has not reported any patient coming to harm. This is a precaution taken before a supply risk becomes a safety incident. **Four weeks is the company's estimate, not a promise.** The MHRA also warns organisations not to assume the strips on the shelf equal four weeks of testing, because more batches may yet fail. **The firmest line in the whole alert is about insulin.** The MHRA tells professionals to tell patients to keep following their prescribed sick-day or insulin plan unless told otherwise, and not to stop using insulin unless a healthcare professional says so. The NHS thresholds have not changed either. For a blood ketone meter, the NHS says under 0.6mmol/L is normal; 0.6 to 1.5mmol/L is slightly high, so retest in two hours; 1.6 to 3mmol/L means you are at risk of DKA and should speak to your diabetes care team; over 3mmol/L is high, may mean you have DKA, and the NHS says call 999 or go to A&E. For urine strips, above 2+ gets the same emergency response. The NHS adds that these are a guide, and your own team may give you different numbers.

Qurexa perspective

We are a healthcare logistics and pharmacy delivery company in Lincolnshire. We do not run diagnostic testing and we are not a diabetes service, so we will stick to the part of this we actually see: people running out of things. A supply alert inside the NHS is not what empties a cupboard at home. But it is a fair prompt to look in the cupboard. Sick-day plans are one of the most useful things a diabetes team gives anyone, and they only work if the items in them are in the house. In our experience it is rarely the insulin that is missing. It is the in-date ketone strips, the spare lancets, or the thing somebody meant to reorder a fortnight ago. If you are one of our customers and you are not sure your repeat prescription covers everything on your sick-day list, tell us or tell your pharmacy. That is a much easier conversation to have on a well day than an ill one. We will also say the plain thing: today's alert asks nothing of patients.

Practical advice

**Keep testing exactly as your team told you to.** Nothing in this alert asks you to change your routine. **Never stop or skip insulin, even if you are not eating.** Both the NHS and the MHRA are explicit about this. If you think a dose needs changing, ring your diabetes team or NHS 111 first. **Learn the symptoms of DKA.** The NHS lists feeling very thirsty, passing urine often, tummy pain, feeling or being sick, diarrhoea, deep or fast breathing, breath that smells fruity or like pear drops, feeling very tired or confused, and blurred vision. **Know when to call 999 or go to A&E.** Blood ketones over 3mmol/L, urine ketones above 2+, or DKA symptoms when you do not know your ketone level. Go too if someone has those symptoms and has never been diagnosed with diabetes. Do not drive yourself, and take your medicines with you. **Check your own supplies this week.** Are your ketone strips in date? Once opened, many have a shorter use-by period. Do you have enough insulin, lancets and glucose? If something is short, order it now rather than at the weekend. **Parents, trust your instincts.** A child who is suddenly very thirsty, going to the toilet constantly, losing weight, tired or breathing deeply needs to be seen the same day. Ask directly: could this be type 1 diabetes? **If you work in the NHS, a care home or home care, read the alert itself** rather than a news summary, including this one. Check which batches your service holds and what your local contingency plan says.

What to know

On 9 October 2026 the MHRA issued alert DSI/2026/013 about Nova Biomedical StatStrip blood ketone test strips. Some batches failed quality-control checks and have been recalled and put on stop-ship. More may fail, so NHS supply could tighten, and the manufacturer says replacement stock is around four weeks away. Blood ketone testing is how staff spot and track diabetic ketoacidosis, so the MHRA has told NHS organisations to check their stock, find alternative testing, and save the strips they have for the highest-risk patients. The Department of Health and Social Care will publish clinical guidance. For patients, the message is short. Nothing changes. Keep testing as instructed, keep taking your insulin, and get urgent help if you have DKA symptoms or a blood ketone reading over 3mmol/L. The affected batch numbers are not in the public alert, so checking stock is an NHS job, not yours. No patient harm has been reported. Sources: MHRA (GOV.UK), 'Nova Biomedical StatStrip ketone test strips: risk of disruption to blood ketone testing due to quality-control failures and supply interruption (DSI/2026/013)', 9 October 2026, https://www.gov.uk/drug-device-alerts/nova-biomedical-statstrip-ketone-test-strips-risk-of-disruption-to-blood-ketone-testing-due-to-quality-control-failures-and-supply-interruption-dsi-slash-2026-slash-013; NHS, 'Diabetic ketoacidosis', https://www.nhs.uk/conditions/diabetic-ketoacidosis/; Patient.info (reproducing the MHRA alert), 'Nova Biomedical StatStrip ketone test strips: risk of disruption to blood ketone testing due to quality-control failures and supply interruption DSI/2026/013', 9 October 2026, https://patient.info/doctor/drug-device-alert/nova-biomedical-statstrip-ketone-test-strips-risk-of-disruption-to-blood-ketone-testing-due-to-quality-control-failures-and-supply-interruption-dsi-slash-2026-slash-013. This article is for general information and does not replace advice from a doctor, pharmacist, diabetes nurse or other qualified healthcare professional. If you think you or someone else may have diabetic ketoacidosis, call 999 or go to A&E.

#diabetes#MHRA#patient safety#ketoacidosis#medical devices#type 1 diabetes

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