MHRA warns of StatStrip ketone strip recall and testing disruption

What Changed

The MHRA’s device safety information DSI/2026/013 reports quality issues affecting specified lots of Nova Biomedical StatStrip ketone test strips. Repeated quality-control (QC) failures have prompted a manufacturer recall, advice not to use affected lots and a distribution pause.

Further lots may need withdrawal if they fail QC testing. Together, these measures could progressively reduce usable supplies and disrupt blood ketone point-of-care testing across the NHS.

Who Is Affected

The notice concerns healthcare organisations using these strips, clinical and point-of-care testing teams, procurement and governance teams, and distributors. Relevant settings include emergency departments, inpatient and paediatric services, ambulance services, primary care and home-based care.

Risk is greatest when patients are acutely unwell, diabetic ketoacidosis (DKA) is suspected or being treated, and no clinically appropriate validated alternative is immediately available. Children and acutely unwell patients with type 1 diabetes are among the priority groups identified.

Regulatory and Technical Implications

This is device safety information; the source does not announce a legislative change. The central concern is continuity of diagnostic and monitoring capacity. Delayed ketone results may delay DKA recognition, escalation, treatment decisions or assessment of treatment response, with potentially serious consequences.

Healthcare organisations are advised to identify held lots, stop clinical use of recalled lots and dispose of them. For non-recalled lots, users should follow the instructions for use. After two consecutive QC failures, the lot should be removed from use, remaining strips disposed of under local procedures, and an alternative lot or blood ketone testing method used.

Organisations should assess usable stock, device numbers and locations, expected stock-out dates and anticipated demand. The notice calls for identifying and validating alternatives and maintaining a documented contingency plan until sufficient confirmed, validated and quality-assured capacity is available.

Manufacturer Actions

Nova Biomedical has recalled specified lots and placed affected lots on stop-ship. Distributors are instructed to follow those arrangements, not supply lots identified as unsuitable, and make end users aware of this notice and relevant Field Safety Notices (FSNs).

The supplied text does not list affected lot numbers or reproduce the accompanying FSN. It therefore cannot, by itself, establish whether an individual stock lot is recalled.

Confirmed Dates

The source gives 9 October 2026 as both the publication and issue date. Nova Biomedical’s approximately four-week estimate for replacement UK stock is not a confirmed resupply date.

The notice states that the Department of Health and Social Care will issue clinical guidance, but provides no publication date.

Official Source

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.

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