Overview
- Up to 10% of NHS laboratories in England were affected, with 16 hospital trusts using the implicated Trinity Biotech systems.
- The issue involves a positive bias in haemoglobin A1C readings that can push borderline results into incorrect type 2 diabetes diagnoses.
- Following MHRA advice issued in July 2025, all affected sites have either replaced the devices or corrected their calibration.
- Problems were first reported to the regulator in April 2024, and Trinity Biotech issued three Field Safety Notices to UK users during 2024.
- Some patients were wrongly prescribed diabetes medication, including metformin, and reported side effects, while a full public list of affected trusts has not yet been released.