Manufactured by Alere – point-of-care tests for use ONLY in professional clinical settings: specific lots are affected.
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.
Genitourinary medicine (GUM) clinics
Deadlines for actions
Actions underway: 17 October 2017
Actions complete: 14 November 2017
Cheshire SK7 5BW
Tel: 07785 387 505
United Healthcare Global Medical
Vantage Point Business Village
Mitcheldean GL17 0DD
Tel: 01594 545 100
Kuehne + Nagel Ltd
Shropshire TF2 8JT
Tel: 0117 332 8676
ANP Pharma Ltd
55 Hainault Road
Leytonstone E11 1EA
Tel: 0208 558 8886
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
- 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
- Obstetrics and gynaecology departments
- Obstetrics and gynaecology directors
- Obstetrics departments
- Obstetrics nurses
- Point of care testing co-ordinators
- Purchasing managers
- Supplies managers
- 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
Establishments registered with the Care Quality Commission (CQC) (England only)
- 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: email@example.com and requesting this facility.
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
Dr Kate Antrobus, Clinical Advisor, Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
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
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
Fax: 0131 314 0722
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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510