MHRA Issues DSI/2026/013 on Nova StatStrip Ketone Test Strips: QC Failures May Disrupt UK Blood Ketone Testing Supply

News Summary

On 9 October 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued Device Safety Information DSI/2026/013, alerting healthcare organisations and the distribution chain in England, Wales, Scotland and Northern Ireland that certain lots of Nova Biomedical's StatStrip ketone test strips have quality problems and repeatedly fail quality control (QC) testing.

The manufacturer has recalled the affected lots and placed them on stop-ship, and has stated that these lots must not be used. MHRA indicates that, if further QC failures occur, additional lots may also be withdrawn from use, which could progressively tighten the supply of blood ketone point-of-care testing (POCT) in the UK. According to MHRA, replacement stock is not expected to be available for approximately four weeks. Healthcare organisations are required to assess their testing capacity, prioritise testing for patients at high risk of diabetic ketoacidosis (DKA), and prepare alternative arrangements.

Published: 12 October 2026, 19:33. Category: Recalls and Safety Notices.

Scope of the Issue

As described by MHRA, the problem is confined to the batch quality of the test strips themselves: the affected lots are associated with repeated QC failures. Nova Biomedical has initiated a recall of the specified lots and designated the affected lots as stop-ship. The manufacturer has also advised that subsequent lots failing QC testing should likewise be withdrawn from use.

MHRA emphasises that the combined effect of the recall, the stop-ship instruction and possible further withdrawals will progressively reduce the number of test strips available for clinical use, thereby disrupting the supply of blood ketone POCT.

Supply Gap and Timeline Expectations

MHRA states that Nova Biomedical does not expect to be able to replenish UK inventory within approximately four weeks. This means healthcare organisations cannot simply divide current stock on hand by average daily usage to estimate how long supplies will last, because further lots may be withdrawn if they fail QC.

The DSI therefore requires users to first establish an inventory of the lot numbers they currently hold and the quantities available, and then to assess testing capacity on that basis, including the number and distribution of blood ketone testing devices, current usable test strip stock, and the projected stock-out date.

Official Clinical Handling Requirements

For lots that have not been recalled, MHRA requires users to follow the instructions for use strictly. If a given lot fails QC testing twice consecutively, users should stop using that lot, dispose of the remaining test strips in accordance with local procedures, and switch to another lot number or to an alternative blood ketone testing method.

Where supply is constrained, the limited testing capacity should be prioritised for patients at the highest clinical risk, including:

• Patients with suspected or confirmed diabetic ketoacidosis (DKA);
• Paediatric patients;
• Patients with acute-onset type 1 diabetes;
• Patients requiring continuous ketone monitoring during DKA treatment.

Organisations should also confirm that escalation arrangements are in place for situations where blood ketone testing is clinically necessary but cannot be performed.

Why This Supply Disruption Matters

In its explanatory section, MHRA notes that blood ketone testing is an important method for identifying and monitoring DKA, and is used across emergency departments, acute inpatient settings, paediatrics, emergency and pre-hospital care, community hospitals, urgent community response, virtual wards, hospital-at-home services, primary care and community nursing.

NHS guidance in the UK indicates that a blood ketone concentration above 3 mmol/L may indicate DKA and requires emergency assessment. NICE also incorporates blood ketone testing into the diagnostic and monitoring pathway for DKA. For children and young people, where DKA is suspected and immediate blood ketone testing is unavailable, NICE recommends immediate transfer to a hospital with acute paediatric capabilities.

MHRA states that reduced testing capacity may lead to delayed identification and assessment of DKA, delayed escalation or transfer, delayed treatment decisions, and impaired monitoring of treatment response. DKA is a potentially life-threatening condition, and such delays may lead to serious deterioration, critical illness, permanent harm or death. The document also notes that the Department of Health and Social Care will issue separate clinical guidance.

Distribution Chain and Information Flow

For the distribution chain, MHRA requires compliance with Nova Biomedical's instructions regarding the affected lots, including recall and stop-ship arrangements; affected lots assessed as unsuitable for use must not be supplied. Distributors must also be prepared to follow up consistently on subsequent safety communications and must ensure that end users are aware of this DSI and the accompanying Field Safety Notice (FSN).

Adverse event reporting channels are as follows:

• England and Wales: the Yellow Card system;
• Scotland: IRIC;
• Northern Ireland: the Yellow Card system, in accordance with the organisation's medical device policy.

Sources and Applicability

Source: UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Safety Information DSI/2026/013, Nova Biomedical StatStrip ketone test strips: risk of disruption to blood ketone testing due to quality-control failures and supply interruption, published 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

Source: MHRA Field Safety Notices for October 2026 listing page, used to cross-check entries and FSN links for the month.

https://www.gov.uk/drug-device-alerts/field-safety-notices-for-october-2026

Scope of verification and access date: The full text of the DSI page above was reviewed (including the summary, clinical and distribution advice, risk explanation, patient information and reporting channels) and cross-checked against the MHRA Field Safety Notices for October 2026 listing page. The access date was 12 October 2026. Lot-level details are governed by the original text of the Field Safety Notices (FSNs) issued by MHRA and the manufacturer; this article does not reproduce lot numbers individually.

Applicability note: This article is an interpretation of publicly available UK MHRA regulatory information and does not constitute a conclusion or commitment regarding any specific product, company or registration application. It concerns UK market Device Safety Information for StatStrip ketone test strips and is distinct from the earlier US FDA recall concerning StatStrip glucose meter software: these involve different products, different failure modes and different regulatory jurisdictions, and the two should not be conflated. Supply timing expectations, clinical prioritisation and handling requirements are governed by the official text and may change with subsequent official updates.

Information Sources

• Medicines and Healthcare products Regulatory Agency (MHRA) - Device Safety Information (DSI/2026/013), 9 October 2026.
• Medicines and Healthcare products Regulatory Agency (MHRA) - Field Safety Notices for October 2026.

AIMEILI Regulatory Interpretation

This alert is a lot-level quality and supply action rather than a device-level withdrawal. The regulatory trigger is repeated QC failure at the user site, which MHRA has accepted as sufficient grounds for the manufacturer to recall specified lots, place them on stop-ship, and signal that additional lots may be withdrawn. For regulatory affairs teams, the key point is that the corrective action is scoped to defined lots while the safety communication, the Field Safety Notice and the DSI carry national reach. That combination is typical of in vitro diagnostic (IVD) strip and reagent quality events, where performance variability is batch-linked and where user-site QC is the primary surveillance mechanism.

The alert also illustrates how MHRA translates a manufacturer's manufacturing and QC issue into clinical contingency instructions. The DSI does not merely repeat the recall; it imposes specific operational duties on users and distributors, including inventory reconciliation by lot, the two-consecutive-QC-failure rule as an operational stop-use threshold, prioritisation criteria for constrained testing capacity, and an explicit escalation requirement where testing cannot be performed. These expectations are directly relevant to post-market surveillance and vigilance files, because they define what competent authorities expect a manufacturer and its distribution chain to communicate when supply of a diagnostic is at risk.

From a vigilance perspective, the reporting routes cited by MHRA - Yellow Card in England, Wales and Northern Ireland, and IRIC in Scotland - should be reflected in the manufacturer's and distributor's complaint and adverse event handling procedures for the UK. Field safety corrective actions of this type should be documented with the same traceability as a device recall: affected lot lists, distribution records, customer acknowledgement, effectiveness checks and closure evidence.

Business Impact for Manufacturers, Distributors, CROs and Regulatory Affairs Teams

For manufacturers, the immediate implications are operational and reputational. Lot-level QC failures that trigger national supply warnings focus regulatory attention on incoming material controls, release testing, stability data and QC specifications for the affected product. Manufacturers should expect follow-up questions on root cause, corrective and preventive action (CAPA) status, release criteria, and the basis for projected resupply timelines. Any public statement about a four-week replenishment window will be treated as a commitment and should be supported by documented manufacturing and logistics planning.

For distributors, the alert converts routine inventory management into a compliance obligation. Distributors must be able to identify affected lots in stock and in the field, quarantine and stop shipment without delay, confirm that end users have received the DSI and the FSN, and retain evidence of those communications. Where alternative products are offered, claims of substitutability must be consistent with the intended use and validated performance of the alternative device, particularly for paediatric and emergency DKA pathways.

For healthcare organisations and their supply partners, the clinical guidance in the DSI creates pressure to diversify ketone testing capability across POCT devices, blood gas analysers and laboratory beta-hydroxybutyrate testing, and to formalise triage and escalation criteria for suspected DKA. Organisations that rely on a single strip platform should treat this event as a case study in single-source diagnostic risk.

For CROs and sponsors, trials in diabetes, DKA management or acute metabolic care that use blood ketone measurements as endpoints, safety parameters or eligibility criteria should review site-level device availability in the UK, assess protocol-defined alternatives, and document any deviations arising from test strip unavailability. Where ketone results feed into safety reporting, the change in testing method or platform should be recorded and, where relevant, reported in accordance with the trial's safety management plan.

For regulatory affairs teams more broadly, the alert is a reminder that supply interruption and quality-control failure can be reportable events in their own right, and that competent authorities may issue national clinical guidance alongside a manufacturer's field safety corrective action. Monitoring MHRA Field Safety Notice listings monthly, maintaining a live mapping of affected product codes and lots, and pre-drafting customer communication templates are practical steps that shorten response time when a comparable alert arises.