Field Safety Notice Nova Biomedical StatStrip® Ketone Test Strips (ICN 3500)

NHSSC: 71

• The Department of Health and Social Care has issued a National Patient Safety Alert, NatPSA/2026/007/NSDR, regarding the supply disruption for Nova Biomedical StatStrip® blood ketone test strips.
• See our Downloads▼ section to access the National Patient Safety Alert, along with Nova Biomedical’s Field Safety Notice and product listing of affected NHS Supply Chain product codes.
• The alert requires actions to be completed by 20 October 2026.
• Organisations should identify a clinical lead and form a working group to act on the Field Safety Notice issued by Nova and follow the advice issued by MHRA in its device safety notice.
• This will include taking action to:
  • Discontinue clinical use and dispose of all lots identified by Nova as subject to recall.
  • Assess current and anticipated blood ketone testing capacity, including the number and location of ketone testing devices, current usable strip stock and anticipated out-of-stock dates.
  • Identify and validate alternative ketone testing methods where available, including alternative point-of-care devices and laboratory testing.
  • Prioritise available blood ketone testing for patients at greatest clinical risk where supply is constrained.

NHSSC: 71

Alert:

• The Medicines and Healthcare products Regulatory Agency (MHRA) has issued Device Safety Information (DSI/2026/013) regarding Nova Biomedical StatStrip® ketone test strips.
• Nova Biomedical issued a Field Safety Notice having identified quality issues affecting specified Lots of StatStrip ketone test strips.
• The affected Lots have been associated with quality-control (QC) failures and Nova Biomedical has initiated a recall advising that these Lots should not be used.
• The primary risk is a delay in obtaining ketone results, which may delay clinical assessment or treatment.
• See our Useful Links section to view DSI from the MHRA.

Products Affected:

• 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.
• The affected product codes are subject to intermittent supply.
• Please note that HHD851 is available to all customers.
• All other product codes are regionally available and not visible to all customers.
• Only the Lot numbers noted in the Field Safety Notice are affected.
• Unfortunately, there are no alternatives available for the affected products.
• See our Downloads▼ section to access the product listing and Field Safety Notice for more information on the affected products codes.
• Nova Biomedical has paused distribution of the affected Lots and advised that any further Lots found to fail 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.
• Nova Biomedical has advised that replacement stock is not expected to be available in the UK for approximately four weeks, which may increase the risk of supply constraints during this period.
• Please see our Useful Links section to view ICN 3503 for the latest information on the supply disruption of the affected products.
• NHS England has issued an 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.

Next Steps:

• Read and follow the full instructions in the DSI and Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all the affected products.
• Complete the customer acknowledgment form, found in page 4 of the notice, and return to EU-QA@novabio.com.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of the affected products in your possession, including national product codes (NPCs), Lot numbers and quantity. Your Customer Service Advisor will give you a unique CMS log number.
• Dispose of the affected products in accordance with your local regulations. Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Service Advisor will raise the appropriate credit.
• Nova’s investigation has not identified performance failures when testing blood samples with affected Lots. The observed issue is related to QC testing and does not indicate a malfunction of the meter.
• For Lots that are not subject to recall, ensure users follow the instructions for use. If a Lot fails QC testing on two consecutive occasions, remove the Lot from use, dispose of any remaining test strips in accordance with local procedures, and switch to an alternative Lot number if available, or use an alternative method for blood ketone testing.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care Team.

Please be aware that in the event of a Field Safety Notice/Product Recall, we may need to provide manufacturers, UK responsible Persons, and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.