Class 2 Medicines : Norgine Pharmaceuticals Limited, Pedmarqsi 80
OFFICIAL-SOURCE RECALL · UNITED KINGDOM
Nova Biomedical StatStrip ketone test strips: disruption to blood Recall: Nova Biomedical has identified
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Nova Biomedical StatStrip ketone test strips: risk of disruption to blood ketone testing due to quality-control failures and supply interruption DSI/2026/013
- Manufacturer
- See official notice
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
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.
Hazard
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.
What consumers should do
for Healthcare Professionals: 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 where supply is constrained, prioritise available blood ketone testing for patients at greatest clinical
Official recall notice
Nova Biomedical StatStrip ketone test strips: risk of disruption to blood ketone testing due to quality-control failures and supply interruption DSI/2026/013
Agency: Medicines and Healthcare products Regulatory Agency
Official publication date: October 9, 2026
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