Karmactive StaffNova Biomedical has recalled specific lots of StatStrip ketone test strips due to repeated quality control failures that could disrupt blood ketone testing across NHS facilities. The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a Device Safety Information notice on 9 October 2026, alerting healthcare providers that affected test strips should not be used. The manufacturer has advised that replacement stock will not be available in the UK for approximately four weeks, creating potential supply constraints during this period.
What Products Are Affected
Nova Biomedical StatStrip Ketone Test Strips are the subject of this recall. The product is listed as part number 46951, with the product name TEST STRIP 50CT KET STRIP DUAL PACK. Eleven specific lot serial numbers have been identified as subject to recall: 2224295249, 2225013249, 2225072249, 2225079249, 2225111249, 2225118249, 2225167249, 2226068249, 2226070249, 2226110249, and 2226173249. Healthcare organisations should verify which lots are currently held in their facilities and immediately discontinue clinical use of any strips matching these lot numbers.
Why Was This Recalled
Nova Biomedical identified quality issues affecting the specified lots, with the affected batches linked to repeated quality control failures. In response, the manufacturer initiated a recall and placed affected lots on stop-ship status. The company has advised that any additional lots subsequently found to fail quality control testing should also be withdrawn from use. This creates potential for a progressive reduction in available test strips and may significantly reduce blood ketone point-of-care testing availability across NHS services. Blood ketone measurement is essential for diagnosing and monitoring diabetic ketoacidosis (DKA), a potentially life-threatening condition. Loss of testing capacity could delay recognition of DKA, delay treatment decisions, or impair monitoring of treatment response.
What You Should Do
Healthcare professionals should establish which lots of Nova Biomedical StatStrips are currently available for clinical use and immediately discontinue use of all recalled lots. For non-recalled lots, ensure users follow instructions for use. If a non-recalled lot fails quality control testing on two consecutive occasions, remove it from use and switch to an alternative lot or alternative testing method if available. Assess current and anticipated blood ketone testing capacity and identify validated alternative ketone testing methods. Where supply is constrained, prioritise available blood ketone testing for patients at greatest clinical risk, including those with suspected or established DKA, paediatric patients, and acutely unwell type 1 diabetes patients.
Patients should continue following their prescribed sick-day and insulin plans unless their healthcare professional advises otherwise. Do not stop using insulin without medical guidance. Keep checking blood glucose frequently using available metres or continuous glucose monitors and report persistent or worsening high blood glucose levels. Seek urgent medical care immediately if experiencing vomiting, abdominal pain, deep or rapid breathing, fruity-smelling breath, marked drowsiness, confusion, severe thirst, dehydration, or progressive illness, as these may indicate DKA.
Official Recall Details
The official MHRA safety notice sets out the regulator’s reference and instructions.
This recall is identified as DSI/2026/013 by the MHRA. The notice was issued on 9 October 2026. Healthcare professionals should report any incidents to the Yellow Card website, the MHRA app, or appropriate regional systems (IRIC in Scotland). Distributors must follow Nova Biomedical’s recall and stop-ship instructions and must not supply unsuitable lots.
Organisations should maintain documented contingency plans until sufficient quality-assured ketone-testing capacity is available to meet clinical demand. For related coverage, see Ozempic Helps 36% of Type 1 Diabetes Patients Hit All Treatment Goals While Placebo Group Shows Zero Success and bettergoods Lemon Alfredo Fettuccine Recall: Listeria Contamination, Walmart Nationwide.
