Medicines and Healthcare products Regulatory Agency gov.uk

Nova Biomedical StatStrip ketone test strips: risk of disruption to blood ketone testing due to quality-control failures and supply interruption DSI/2026/013

Imported from official source

October 09, 2026 15:44 Alert

Safety Classified by Officially

Nova Biomedical has 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. Nova Biomedical has also paused distribution of the affected lots and advised that any further lots found to fail QC testing should also be withdrawn from use.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 4 weeks, which may increase the risk of supply constraints during this period.

if your organisation uses Nova Biomedical StatStrips, establish which lots are currently held and available for clinical use

discontinue clinical use and dispose of all lots identified by Nova Biomedical as subject to recall

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

do not assume that the current quantity of strips represents the duration of available supply, as additional lots may become unavailable if there is QC failure

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

This is an extract. The publication continues at the source.

Contains public sector information licensed under the Open Government Licence v3.0. Licence

Read the original at the source: 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

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Organization: Medicines and Healthcare products Regulatory Agency — imported from official source
Official source: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency.atom ATOM
Imported: October 09, 2026 16:01
Versions: 1 recorded
Identity: https://www.gov.uk/drug-device-alerts/nova-biomedical-statstrip-ketone-test-strips-risk...