Medical Device Alert: Histology laboratory reagents: Primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15). Labelled NovocastraTM and BondTM both manufactured by Leica Biosystems (MDA/2012/006)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/006 or 2012/001/026/601/002

Technical aspects

Mrs Mojisola Ajeneye or Dr Rosalind Polley
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel:    020 3080 7271/7119
Fax:   020 8754 3965

Email:    mojisola.ajeneye@mhra.gsi.gov.uk or rosalind.polley@mhra.gsi.gov.uk

Clinical aspects

Dr Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel:    020 3080 7126
Fax:   020 8754 3965

Email:    nicola.lennard@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices 
Further information about CAS can be found on the CAS website (external link)

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ

Tel:    02890 523 704
Fax:   02890 523 900
Email:    NIAIC@dhsspsni.gov.uk

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website (external link)
Further information about SABS can be found on the SABS website (external link)

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB

Tel:    0131 275 7575
Fax:   0131 314 0722

Email:    nss.iric@nhs.net

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC) (external link)

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ

Tel:    029 2082 3922
Email:    Haz-Aic@wales.gsi.gov.uk

Primary antibody to CD2 (clone 11F11) has been labelled as CD7 (clone LP15).

Conversely, primary antibody to CD7 (clone LP15) has been labelled as CD2 (clone 11F11).

Leica Biosystems issued a Field Safety Notice (128Kb) warning that various lot numbers of the products listed, primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15), have been mislabelled during the manufacturing process. The product labelled as CD2 is actually CD7 antibody and the product labelled as CD7 contains CD2 antibody.

Where staining with CD2 antibody occurs instead of the expected CD7 antibody this may lead to the failure to identify a reduction in CD7 expression and a potential delay in the diagnosis of lymphoma.

The investigation into the root cause of this issue is ongoing.

• Do not use affected lots
• Referral centres/service providers who have used the affected lots should consider the need to review and retest previous results.
• Referral centres/laboratories undertaking confirmatory testing should consider informing referring laboratories of your review where relevant.
• Contact your reference laboratory if you need advice on a suitable approach to risk assessment.

Action by

Reference laboratories
Biomedical scientists (histologists)
Clinical services managers
Directors of pathology
Medical oncologists

This MDA has been sent to:

• NHS trusts in England (Chief Executives)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Equipment Co-ordinators)
• NHS boards and trusts in Wales (Chief Executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment.  Below is a suggested list of recipients.

Trusts

CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• Chief executives
• Clinical governance managers
• Clinical pathologists
• Clinical pathology directors
• Haematologists
• Haematology, directors of
• Histologists
• Medical directors
• Medical oncologists
• Medical oncology, directors of
• Nursing executive officer
• Purchasing managers
• Risk managers
• Supplies managers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

This alert should be read by:

• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

Rachel Osborne
Leica Biosystems Newcastle Ltd
Balliol Business Park West
Benton Lane
Newcastle upon Tyne
NE12 8EW

Tel:    0191 215 0567
Fax:   0191 215 1152

Email:    rachel.osborne@leicamicrosystems.com

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk