BRIEF-MHRA Receives Reports Of Trinity Biotech's Analyser Incorrectly Diagnosing Patients As Pre-Diabetic Or Diabetic

Reuters

07/22

BRIEF-MHRA Receives Reports Of Trinity Biotech's Analyser Incorrectly Diagnosing Patients As Pre-Diabetic Or Diabetic

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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