- Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice, and that they understand the problem and the actions to be taken.
- Affected lots may only be used if same slide controls are used.
- Users who do not use same slide controls should not use affected lots, and are advised to destroy affected kits, and request replacement kits from the manufacturer.
- The use of appropriate same slide controls is highly recommended as it helps ensure the efficacy of all Immunohistochemistry (IHC) assays carried out on every slide on an automated IHC instrument.
- Consider the need to review previous test results obtained using affected lots.
- If any adverse event occurs relating to this issue, please report this to MHRA via Yellow Card or the relevant devolved administrations (Scotland, Wales and Northern Ireland).
- Directors of pathology
- Laboratory managers
- Lead biomedical scientists (Cytologists / Histologists)
- Purchasing Managers
- General Surgeons
Deadlines for actions
Actions underway: 1 March 2018
Actions complete: 15 March 2018
Problem / background
The manufacturer has informed the MHRA of increased customer complaints reporting leaking and sticking of the reagent dispenser, which could result in the failure of a reagent critical to the staining reaction (light or absent staining).
These devices are used to detect markers in a range of pathological conditions including those associated with cancer (e.g. HER2,ER/PR, ALK and PD-L1).
As a consequence, there is a risk of false negative results (e.g. with all companion diagnostics such as HER2 tests) affecting clinical decisions for patients, due to commence treatment.
Dispenser issues with Hematoxylin II and Horseradish Peroxide Reagents which are used in the following kits:
|OptiView DAB IHC Detection Kit
||Y19271, Y11625, Y15571
|OptiView Amplification Kit
||Y15435, Y19322, Y22447
|UltraView Universal DAB Detection Kit
||Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069
||Y10759, Y17402, Y21312, Y13938, Y17403
Roche Diagnostics Ltd
West Sussex RH15 9RY
Registration Number: 571546
Technical Support Hotline (UK): 08081 001 920
- Public Health England (for information)
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- Biomedical science departments
- Clinical governance leads
- Clinical pathologists
- Clinical pathology directors
- General surgeons
- Medical directors
- Medical oncologists
- Medical oncology, directors of
- Radiation & medical oncology departments
- Risk managers
- Equipment stores
- Supply managers
Establishments registered with the Care Quality Commission (CQC) (England only)
- Private medical practitioners
- Independent treatment centres
- Hospitals in the independent sector
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2018/005 or 2017/012/022/291/012.
Bina Mackenzie, MHRA
Tel: 0203 080 7229
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
Through Yellow Card
Alerts in Northern Ireland are distributed via the NICAS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Northern Ireland Adverse Incident Centre (NIAIC)
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Private facilities providing care to private clients report to the Care Inspectorate and MHRA.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).