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Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as a diagnostic aid in diabetes mellitus (DSI/2025/003)

Published

22 July 2025

Source

Alerts and Recalls for Drugs and Medical Devices - General Practice

Imported

5 Aug 2026

Original alert

https://www.gov.uk/drug-device-alerts/t…

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…

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Important: This alert is aggregated automatically for information only. Always refer to the original source and follow your practice's own clinical governance procedures.

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Alerts and Recalls for Drugs and Medical Devices - General Practice

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