Roche Tissue Diagnostics (Ventana Medical Systems) – OptiView DAB IHC Detection Kit, UltraView Universal DAB Detection Kit, OptiView Amplification Kit and Hematoxylin II – Dispenser failure of Hematoxylin II and Horseradish Peroxidase reagents

Roche Tissue Diagnostics (Ventana Medical Systems) – Leaking and sticking reagent dispensers may cause weak staining on tissue samples, which may lead to false negatives and misdiagnosis.


  • 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).

Action by

  • Directors of pathology
  • Laboratory managers
  • Lead biomedical scientists (Cytologists / Histologists)
  • Purchasing Managers
  • Oncologists
  • 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.

Device details

Dispenser issues with Hematoxylin II and Horseradish Peroxide Reagents which are used in the following kits:

Product Name Roche DMS Lots
OptiView DAB IHC Detection Kit 06396500001 Y19271, Y11625, Y15571
OptiView Amplification Kit 06396518001 Y15435, Y19322, Y22447
UltraView Universal DAB Detection Kit 05269806001 Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069
Hematoxylin II 05277965001 Y10759, Y17402, Y21312, Y13938, Y17403

Manufacturer contacts

Roche Diagnostics Ltd
Charles Avenue
Burgess Hill
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

Independent distribution

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: and requesting this facility.



Send enquiries about this notice to MHRA, quoting reference number MDA/2018/005 or 2017/012/022/291/012.

Technical aspects

Bina Mackenzie, MHRA
Tel: 0203 080 7229

Clinical aspects

Devices Clinical Team, MHRA
Tel: 020 3080 7274

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

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,
Welsh Government

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).

Download documents

Roche Tissue Diagnostics (Ventana Medical Systems) – OptiView DAB IHC Detection Kit, UltraView Universal DAB Detection Kit, OptiView Amplification Kit and Hematoxylin II – Dispenser failure of Hematoxylin II and Horseradish Peroxidase reagents.

Published 15 February 2018