Faulty diabetes test machines leave at least 55,000 in England needing retests
NHS England confirms 16 trusts used Trinity Biotech analysers that produced inaccurate haemoglobin A1C results; MHRA and manufacturer investigating
Errors by laboratory analysers used to diagnose and monitor diabetes have left at least 55,000 people in England facing additional blood tests, NHS England and the manufacturer said, after a BBC investigation revealed widespread inaccuracies.
NHS England confirmed that 16 hospital trusts have used devices made by Trinity Biotech that produced inaccurate haemoglobin A1C results, the blood test commonly used to diagnose type 2 diabetes and to monitor glucose control in people with the condition. Some patients were wrongly given a diagnosis of type 2 diabetes and prescribed medication they do not need, officials said, and there could be more people affected.
The issue first emerged publicly in September 2024, when the BBC reported that about 11,000 patients at Luton and Dunstable Hospital faced retesting after a single analyser issued incorrect results. NHS England said the problem has since been identified in other sites and that the additional total of affected patients now stands at a minimum of 55,000. The health service also reported an increase in recorded type 2 diabetes diagnoses in 2024 of roughly 10,000 — about 4% higher than expected — a rise officials say requires further scrutiny in light of the test issues.
Trinity Biotech said it is working closely with the UK medicines and healthcare products regulator, the MHRA, and has contacted all hospitals that use the affected analysers. The company and regulators have not said whether a manufacturing fault, reagent problem, calibration error or other cause is responsible; investigations are ongoing.
The haemoglobin A1C test measures average blood glucose levels over several months and is widely used both to make a diagnosis of type 2 diabetes and to monitor long-term blood sugar control in people with diabetes. Clinicians use the test result, along with clinical assessment, to determine whether to start or adjust glucose-lowering treatments.
NHS England said the number of people needing retesting relates to results produced by the specified Trinity Biotech analysers and that trusts are being supported to identify and recall affected patients for repeat testing and clinical review. Some patients who received an incorrect diagnosis were started on medication; clinicians will need to review individuals' records to decide whether treatment should be continued, adjusted or stopped.
The MHRA said it is aware of the reports and is working with NHS organisations and the manufacturer to assess the risk and determine appropriate regulatory action. Trinity Biotech has said it has proactively contacted customers and is cooperating with the regulator and hospital laboratories.
Laboratory errors that affect diagnosis can have significant implications for patients, including psychological distress and exposure to unnecessary medication. NHS organisations have been asked to prioritise contacting and retesting people whose care may have been affected while investigations continue. Patients concerned about a recent haemoglobin A1C test are advised to contact their GP or the hospital where the test was performed for advice and to confirm whether they are affected.
Health officials and the manufacturer said further information will be published as investigations progress and any corrective actions are implemented to ensure test accuracy and patient safety.
