Nova Biomedical's ketone strip QC failures left UK hospitals facing a testing shortage

On 9 October 2026 the UK's MHRA issued a device safety alert (DSI/2026/013) over Nova Biomedical's StatStrip ketone test strips. Nova had identified quality issues affecting specified lots, associated with repeated quality-control failures, and initiated a recall of those lots. It also placed affected lots on stop-ship and advised that any further lots found to fail QC testing should be withdrawn from use too.

The strips are the standard near-patient test for blood ketones across NHS emergency departments, ambulance services, paediatric wards, community hospitals and virtual wards — the diagnostic pathway for diabetic ketoacidosis, where readings above 3 mmol/L trigger emergency assessment. The alert warned the recall, paused distribution and potential further withdrawals could progressively reduce availability, with replacement UK stock not expected for approximately four weeks.

Hospitals were told to inventory their lots, dispose of recalled ones, pull any lot failing QC on two consecutive runs, identify and validate alternative testing methods, and prioritise remaining strips for patients at greatest clinical risk, including suspected DKA cases and acutely unwell children with type 1 diabetes.

Recalled and stop-shipped lots risk a progressive UK shortage of ketone strips; replacement stock was not expected for about four weeks, disrupting DKA testing.

Quality-control failures recurred across lots, so the recall list could keep growing — the alert explicitly warned additional lots might become unavailable.

The strips are the sole near-patient ketone method for many NHS services, and Nova could not replenish UK stock for roughly four weeks.

Hospitals were left to build rationing plans themselves: validate alternatives, conserve remaining strips, and prioritise the highest-risk patients.

A consumable with no validated alternative is a single point of failure: when quality control catches your defects, the supply chain catches your customers.

The MHRA told providers to establish which lots they hold, discontinue and dispose of recalled lots, and put escalation arrangements in place where ketone testing becomes unavailable; distributors were told not to supply lots identified as unsuitable. Nova advised UK stock would return in about four weeks. The alert reports the risk and interim workflow; it does not report any confirmed patient harm.