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)
Recall Summary The Trinity Biotech Premier Hb9210 HbA1c Analyser, a device used to measure blood sugar levels for diabetes diagnosis, is being recalled because it produces results that are consistently higher than they should be. This has led to patients being incorrectly diagnosed with pre-diabetes or diabetes when they may not actually have these conditions. The device is distributed in the United Kingdom.
- Recalling firm
- Risk of Positive Bias and Updates to Instructions for Use (IFU)
- Reason
- 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.
- Classification
- Unclassified
- Category
- drug recall
- Country
- United Kingdom
- Agency
- UK Medicines and Healthcare products Regulatory Agency
- Recall date
- 2025-07-22
- Status
- Ongoing
- Distribution
- United Kingdom
Official recall notice from UK Medicines and Healthcare products Regulatory Agency
Recall details on Nibble Recalls: https://trynibble.app/recalls/8d4fc8c4-8732-426d-9cc9-507e0eda9a96