Brief: MHRA Receives Reports Of Trinity Biotech's Analyser Incorrectly Diagnosing Patients As Pre-Diabetic Or Diabetic
22/07/2025 14:33
July 22 (Reuters) - UK's MHRA: MHRA: RECEIVED REPORTS DESCRIBING POSITIVE BIAS IN HBA1C RESULTS DELIVERED BY TRINITY BIOTECH PREMIER HB9210 HBA1C ANALYSER MHRA: POSITIVE BIAS IN HBA1C RESULTS RESULTED IN PATIENTS BEING INCORRECTLY DIAGNOSED AS PRE-DIABETIC OR DIABETIC. MHRA: TRINITY BIOTECH COMMITTED TO UPDATING INTENDED USE STATEMENT IN THE INSTRUCTIONS FOR USE ((Reuters.Briefs@thomsonreuters.com;))
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