Device Safety Information - DSI/2025/003

The MHRA has received reports describing a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed as pre-diabetic or diabetic. The MHRA is working closely with the manufacturer, Trinity Biotech, to resolve this. In addition, Trinity Biotech has committed to updating the Intended Use statement in the Instructions for Use (IFU), to include the use of the analyser as a diagnostic aide, and to provide further clarity regarding the frequency of preventative maintenance required to ensure the consistent performance of the analyser.