Supply Issues Nova StatStrip® Ketone Test Strips (ICN 3503)

Change:

• The supplier Nova Biomedical has informed us of a supply issue with its StatStrip® ketone test strips.
• One product is affected:
  • Supplier Code: 46951 – Blood Ketone Test Strips For use with StatStrip Meters.
• The affected product is supplied through seven NHS Supply Chain product codes due to regional grouping:
  • HHD851 − Ketone test strips for use with StatStrip Meters
  • HHD85007 − Ketone test strips for use with StatStrip Meters
  • HHD412 − Ketone test strips for use with StatStrip Meters
  • HHD722 − Ketone test strips for use with StatStrip Meters
  • HHD835 − Ketone test strips for use with StatStrip Meters
  • HHD839 − Ketone test strips for use with StatStrip Meters
  • HHD553 – Ketone test strips for use with StatStrip Meters.
• Please note that HHD851 is available to all customers.
• All other product codes are regionally available and not visible to all customers.
• The supply issue is due to the supplier issuing a Field Safety Notice having identified quality issues affecting specified Lots of StatStrip® ketone test strips.
• The MHRA has issued Device Safety Information (DSI/2026/013) regarding the recall and supply of the affected product.
• See our Useful Links section to view Field Safety Notice ICN 3500 for more information on the product recall and to view DSI from the MHRA.

Impact:

• Nova Biomedical has paused distribution of the affected Lots and advised that any further Lots found to fail quality-control (QC) testing should also be withdrawn from use.
• The recall, paused distribution, and potential withdrawal of additional Lots may result in a progressive reduction in the availability of ketone test strips and disruption to blood ketone point-of-care testing.
• NHS England has issued Interim clinical prioritisation guidance for blood ketone testing during the supply disruption.
• See our Useful Links section to view the interim clinical prioritisation guidance issued by NHS England.
• The affected product codes are subject to intermittent supply.
• Unfortunately, there are no alternatives available.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes.
• Nova is currently expecting new product to be available during the week commencing 26 October 2026.
• The supply issue is anticipated to be resolved in approximately four weeks.

Next Steps:

• Customers are advised to log into our website to view the product listing for further information on the affected product codes.
• Should you have any questions please contact Nova Biomedical UK:
  • Telephone: +44 1928 704047
  • Email: EU-QA@novabio.com.
• NHS Supply Chain is in daily contact with Nova, Department of Health and Social Care (DHSC) and NHS England and we will update this ICN as soon as we have further information.
• If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.

Please note that due to the clinical nature of these alternative products, we advise you to consult your own clinical experts to ensure suitability for your organisation’s use of these products.