Professional use HIV test: Alere HIV Combo – risk of false positive results

Manufactured by Alere – point-of-care tests for use ONLY in professional clinical settings: specific lots are affected.

Action

  • Identify affected devices, which are listed in the manufacturer’s Field Safety Notice (FSN).

  • Where affected devices have been used, ensure that initially reactive p24 antigen and/or antibody results that were obtained from EDTA whole blood samples are retested using another method.

  • Ensure the results are evaluated in consideration of the overall clinical evaluation before a diagnosis is made.

  • Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice (FSN). and that they understand the problem and to check that the actions have been taken.

Action by

  • Genitourinary medicine (GUM) clinics

  • General practitioners

  • Pharmacists

  • Purchasing managers

Deadlines for actions

Actions underway: 17 October 2017

Actions complete: 14 November 2017

Manufacturer

Simon Richards
Alere Ltd
Pepper Road
Hazel Grove
Stockport
Cheshire SK7 5BW

Tel: 07785 387 505

simon.richards@alere.com

UK distributors

United Healthcare Global Medical
Buliding 8
Vantage Point Business Village
Mitcheldean GL17 0DD

Tel: 01594 545 100

phil.hughes@unitedhealthcareglobal.com

Kuehne + Nagel Ltd
LCS Services
Shropshire TF2 8JT

Tel: 0117 332 8676

leidos-tvs-med-techcon1b@mod.uk

ANP Pharma Ltd
55 Hainault Road
Leytonstone E11 1EA

Tel: 0208 558 8886

info@anppharma.co.uk

Distribution

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 pathologists
  • Gynaecologists
  • Gynaecology departments
  • Gynaecology nurses
  • Hospital pharmacies
  • Hospital pharmacists
  • Infection control departments
  • Infection control nurses
  • Infection prevention and control directors
  • Medical directors
  • NHS walk-in centres
  • Obstetricians
  • Obstetrics and gynaecology departments
  • Obstetrics and gynaecology directors
  • Obstetrics departments
  • Obstetrics nurses
  • Point of care testing co-ordinators
  • Purchasing managers
  • Supplies managers
  • Virologists
  • Walk-in centres

Public Health England

Directors for onward distribution to:

  • Collaborating centres
  • Consultants in communicable disease control
  • Divisional directors
  • Heads of department
  • Health protection nurses
  • PHE laboratories
  • Laboratory managers
  • Regional microbiologists
  • Risk manager
  • Safety officers

NHS England area teams

CAS liaison officers for onward distribution to all relevant staff including:

  • General practice managers
  • General practice nurses

Independent distribution

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

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

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: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2017/033 or 2017/007/017/291/028.

Jazmin McCalla-Bedward, MHRA

Tel: 020 3080 6270

jazmin.mccalla-bedward@mhra.gov.ukk

Clinical aspects

Dr Kate Antrobus, Clinical Advisor, Devices Clinical Team, MHRA

Tel: 020 3080 7274

DCT@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Alerts in Northern Ireland are distributed via the NI SABS 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

Email: niaic@health-ni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

Please report directly to NIAIC using the forms on our website.

Scotland

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

Fax: 0131 314 0722

Email: nss.iric@nhs.net

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.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government

Tel: 02920 823 624 / 02920 825 510

Email: Haz-Aic@wales.gsi.gov.uk

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

MDA/2017/032 - Professional use HIV test: Alere HIV Combo - risk of false positive results [InlineAttachment:MDA-2017-033_Final.pdf]

Published 3 October 2017