The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert regarding the Trinity Biotech Premier Hb9210™ HbA1c analyser following reports of a positive bias in the device’s results. This anomaly has led to patients being incorrectly diagnosed as pre-diabetic or diabetic, creating significant implications for healthcare providers and affected individuals.
What changed?
In its notification dated October 2, 2025, the MHRA highlighted a pattern identified in requested reports, showing a consistent positive bias in the HbA1c results produced by the Trinity Biotech Premier Hb9210™ analyser. This positive bias may result in overestimated glycated hemoglobin values, which could incorrectly categorize patients as pre-diabetic or diabetic. The manufacturer has updated the device’s Instructions for Use (IFU) to address this issue.
Healthcare providers are advised to reassess their diagnostic processes for diabetes mellitus, especially where results from the affected analyser have influenced patient treatment plans.
Who is affected?
Primary stakeholders include clinical, quality, and regulatory teams within medical institutions using the Premier Hb9210™ analyser for HbA1c testing. Patients who received diabetes or pre-diabetes diagnoses based on the analyser’s output may also be impacted.
The MHRA urges medical professionals to evaluate any irregular diagnostic trends that coincide with the use of this device and to follow updated guidelines when interpreting results.
Manufacturer response
Trinity Biotech has acknowledged the findings and undertaken corrective actions to mitigate risks associated with the positive bias. Updates to the IFU reflect improved recommendations for using the analyser as a diagnostic aid for diabetes mellitus. The company advises healthcare providers to integrate these updates into their protocols.
While steps have been taken to address the issue, close monitoring of device outputs remains integral to ensuring diagnostic accuracy. The MHRA continues to evaluate developments related to the analyser to ensure patient safety.
What the IFU Update Includes
- Revised instructions for interpreting HbA1c results
- Guidance on when to consider confirmatory testing
- Specific warnings about potential positive bias
Professionals are encouraged to download and review the updated IFU directly via the Trinity Biotech website or official distribution channels.
Frequently Asked Questions
1. How can healthcare providers identify the positive bias?
If HbA1c results show unexpected elevations inconsistent with patient clinical profiles, confirmatory tests or alternative diagnostic methods should be utilized.
2. Should patients with prior diagnoses be re-evaluated?
It is recommended that healthcare providers reassess diagnoses made using this analyser, particularly for patients whose results fall marginally within pre-diabetic or diabetic ranges.
3. Are all devices affected?
The positive bias issue is specific to the Trinity Biotech Premier Hb9210™ HbA1c analyser. Devices from other manufacturers are not implicated in this notice.
Actions for healthcare professionals
Clinicians, laboratory managers, and regulatory professionals should take the following steps:
- Review the MHRA alert and updated IFU from Trinity Biotech
- Educate staff on recognizing and adjusting for potential positive bias
- Perform confirmatory testing where HbA1c readings influence treatment decisions
- Reassess patient records, diagnoses, and treatment plans linked to the analyser’s outputs
Remaining vigilant and implementing appropriate mitigation strategies is critical to minimizing diagnostic inaccuracies.
Disclaimer
This article is intended for healthcare professionals and regulatory teams. It is informational in nature and should not be construed as legal or medical advice. Consult official MHRA notifications and Trinity Biotech documentation for specific guidance.
For full information about the announcement, see the link below.
https://www.gov.uk/drug-device-alerts/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-slash-2025-slash-003