Device safety informationMHRA
Trinity Biotech Premier Hb9210™ HbA1c Analyser safety warning over inaccurate results
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.
What to do now
Tests using affected Trinity Biotech Premier Hb9210™ HbA1c Analyser may be unreliable.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. An inaccurate result can lead to the wrong treatment decision, so affected kits or strips should not be relied on.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2025/003). Quoted as issued.
Summary
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.
The risk
Summary 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. The MHRA is working closely with the manufacturer, Trinity Biotech, to resolve this. In addition, Trinity Biotech, has committed to updating the Intended Use statement in the Instructions for Use (IFU), to include the use of the analyser as a diagnostic aide, and to provide further clarity regarding the frequency of preventative maintenance required to ensure the consistent performance of the analyser. Advice for healthcare professionals:
Advice for healthcare professionals
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. The MHRA is working closely with the manufacturer, Trinity Biotech, to resolve this. In addition, Trinity Biotech, has committed to updating the Intended Use statement in the Instructions for Use (IFU), to include the use of the analyser as a diagnostic aide, and to provide further clarity regarding the frequency of preventative maintenance required to ensure the consistent performance of the analyser.
the Trinity Biotech Premier Hb9210 HbA1c analyser IFU Intended use statement will be updated to state that results from the analyser can be used as an aid to the diagnosis for diabetes mellitus
where HbA1c measurements are taken, ensure that you are familiar with the information presented in the recent Field Safety Notices (FSNs) (see below), issued by the manufacturer, and the Operator’s Manual, to use the analyser accurately (refer to ‘Explanation of identified safety issue’ section below)
if you are using the Trinity Biotech Premier Hb9210 HbA1c Analyser and notice a change in the performance of the analyser that falls outside the manufacturer’s expected tolerance, please report the details to Trinity Biotech and the MHRA. Please see our reporting section below for details of how to report to the MHRA
it is advised to closely monitor performance with independent Quality Control material, and to consider appropriate corrective action if significant changes in performance are detected
consider whether recalling and retesting is required for any patients newly diagnosed as diabetic between April 2024 to the present
to seek medical attention immediately if adversely affected following any changes to medication, such as hypoglycaemia (shaking/trembling, sweating, confusion, loss of consciousness) or hyperglycaemia (excessive thirst, blurred vision, recurrent infections)
please ensure that end users are familiar with this DSI, the FSNs and the relevant manufacturer’s IFU
Advice for patients
to seek medical attention immediately if adversely affected following any changes to medication, such as hypoglycaemia (shaking/trembling, sweating, confusion, loss of consciousness) or hyperglycaemia (excessive thirst, blurred vision, recurrent infections)
Open the MHRA notice
Questions
Why has Trinity Biotech Premier Hb9210™ HbA1c Analyser been recalled?
Tests using affected Trinity Biotech Premier Hb9210™ HbA1c Analyser may be unreliable. An inaccurate result can lead to the wrong treatment decision, so affected kits or strips should not be relied on.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.