mhra
MHRA flags CRRT filter adsorption and StatStrip ketone testing risks
MHRA’s October 2026 Safety Roundup highlights antifungal adsorption during CRRT and potential disruption to ketone testing following StatStrip quality failures.
What Changed
The Medicines and Healthcare products Regulatory Agency (MHRA) has highlighted two medical-device safety issues in its October 2026 Safety Roundup: drug adsorption during continuous renal replacement therapy (CRRT) and potential disruption to blood ketone testing involving Nova Biomedical StatStrip strips.
Caspofungin can bind to polyacrylonitrile (PAN)-based CRRT membranes, potentially causing ineffective antifungal treatment with life-threatening consequences in critically ill patients. Separately, quality-control failures affecting specified StatStrip lots have prompted a manufacturer recall and a pause in distribution of affected lots.
Who Is Affected
The CRRT advice concerns teams setting up and managing treatment, together with professionals prescribing, dispensing and administering caspofungin. The StatStrip notice affects clinical, point-of-care testing, procurement and governance teams in organisations using these ketone strips.
Patients at greatest risk from constrained ketone-testing capacity include those with suspected or established diabetic ketoacidosis (DKA), children, acutely unwell people with type 1 diabetes and patients needing serial measurements during DKA treatment.
Regulatory and Technical Implications
Adsorption risk is considered greatest when a new membrane or filter circuit starts and decreases as the membrane becomes saturated. Where possible, MHRA recommends administering echinocandins such as caspofungin, and similar drugs, at least six hours after starting PAN-based filter use or changing the filter circuit.
CRRT should proceed as clinically indicated and should not be delayed or paused solely for drug administration unless the responsible clinician considers this necessary. The same adsorption risk cannot be excluded for other membrane types or drugs with similar properties. Providers should review local protocols and consider adsorption when treatment responses are inadequate.
Manufacturer Actions
Nova Biomedical has initiated a recall and paused distribution of affected lots. Healthcare organisations should discontinue clinical use and dispose of recalled lots. For lots outside the recall, users should follow the instructions for use; a lot failing quality-control testing twice consecutively should also be removed, with remaining strips disposed of under local procedures.
MHRA advises assessing usable stocks and anticipated exhaustion dates, validating alternative testing methods and implementing contingency arrangements. Existing strip quantities may overstate future availability if further lots fail quality control. The roundup announces no new manufacturer submission or conformity-assessment obligation.
Confirmed Dates
The roundup was published on 27 October 2026 and updated on 30 October 2026. The later revision added a Direct Healthcare Professional Communication about antidepressants.
Nova Biomedical advised that replacement UK stock was not expected for approximately four weeks. No fixed replenishment date is stated, so this estimate should not be treated as a confirmed delivery commitment.
Official Source
MHRA, MHRA Safety Roundup: October 2026. Affected StatStrip lot numbers are not listed in the roundup; the recall scope should be checked against Nova Biomedical’s notification.
Https://www.gov.uk/drug-device-alerts/mhra-safety-roundup-october-2026
Source and related services
MHRA Safety Roundup: October 2026 ↗Source date: 30/10/2026
This news provides general information and does not replace device-specific legal or conformity assessment advice.