RightSign HIV 1.2.O Rapid Test Cassette, HCV Rapid Test Cassette & HBsAg Rapid Test Cassette – devices may give incorrect results that could lead to a missed diagnosis.

Manufactured by Hangzhou Biotest Biotech Co Ltd: certain lots of these devices may give an incorrect false negative or false positive result when testing for HIV, HCV and HBV. These are point of care tests intended for use ONLY in professional clinical settings.

Action

  • Do not use these device.
  • Identify and dispose of the devices affected by this action.
  • Where affected devices have been used, recall and re-test patients.
  • 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.

Action by

  • Genitourinary medicine (GUM) clinics
  • Sexual health clinics
  • General Practitioners
  • Healthcare professionals using these devices
  • Purchasing managers

Deadlines for action

Action underway: 01 August 2016

Action complete: 16 August 2016

Device details

Example box containing affected devices

RightSign

Catalogue number Name Brand Lot No.
IHBSG-C31 HBsAg Rapid Test Cassette(Serum/Plasma)(CE2265) RightSign HBSG14060001
IHBSG-C31 HBsAg Rapid Test Cassette(Serum/Plasma)(CE2265) RightSign HBSG1410001
IHBSG-C31 HBsAg Rapid Test Cassette(Serum/Plasma)(CE2265) RightSign HBSG15040001
IHBSG-C31 HBsAg Rapid Test Cassette(Serum/Plasma)(CE2265) RightSign HBSG15040002
IHBSG-C31 HBsAg Rapid Test Cassette(Serum/Plasma)(CE2265) RightSign HBSG15050005
IHBSG-C31 HBsAg Rapid Test Cassette(Serum/Plasma)(CE2265) RightSign HBSG15060003
IHBSG-C31 HBsAg Rapid Test Cassette(Serum/Plasma)(CE2265) RightSign HBSG15080001
IHBSG-C31 HBsAg Rapid Test Cassette(Serum/Plasma)(CE2265) RightSign HBSG15120003
IHBSG-C31 HBsAg Rapid Test Cassette(Serum/Plasma)(CE2265) RightSign HBSG16030001
IHBSG-C31 HBsAg Rapid Test Cassette(Serum/Plasma)(CE2265) RightSign HBSG16050014
IHCV-C31 HCV Rapid Test Cassette (Serum/Plasma)(CE2265) RightSign HCV14060001
IHCV-C31 HCV Rapid Test Cassette (Serum/Plasma)(CE2265) RightSign HCV14100001
IHCV-C31 HCV Rapid Test Cassette (Serum/Plasma)(CE2265) RightSign HCV15050007
IHCV-C31 HCV Rapid Test Cassette (Serum/Plasma)(CE2265) RightSign HCV15050008
IHCV-C31 HCV Rapid Test Cassette (Serum/Plasma)(CE2265) RightSign HCV15090007
IHCV-C31 HCV Rapid Test Cassette (Serum/Plasma)(CE2265) RightSign HCV15110001
IHCV-C31 HCV Rapid Test Cassette (Serum/Plasma)(CE2265) RightSign HCV15110002
IHCV-C31 HCV Rapid Test Cassette (Serum/Plasma)(CE2265) RightSign HCV16030007
IHIV-C42 HIV 1.2.O Rapid Test Cassette(Whole Blood/Serum/Plasma)(CE2265) RightSign HIV14060001
IHIV-C42 HIV 1.2.O Rapid Test Cassette(Whole Blood/Serum/Plasma)(CE2265) RightSign HIV14060002
IHIV-C42 HIV 1.2.O Rapid Test Cassette(Whole Blood/Serum/Plasma)(CE2265) RightSign HIV14100001
IHIV-C42 HIV 1.2.O Rapid Test Cassette(Whole Blood/Serum/Plasma)(CE2265) RightSign HIV14100002
IHIV-C42 HIV 1.2.O Rapid Test Cassette(Whole Blood/Serum/Plasma)(CE2265) RightSign HIV15080003
IHIV-C42 HIV 1.2.O Rapid Test Cassette(Whole Blood/Serum/Plasma)(CE2265) RightSign HIV15110001
IHIV-C42 HIV 1.2.O Rapid Test Cassette(Whole Blood/Serum/Plasma)(CE2265) RightSign HIV16020005
IHIV-C42 HIV 1.2.O Rapid Test Cassette(Whole Blood/Serum/Plasma)(CE2265) RightSign HIV16050008

Problem / background

The manufacturer issued a Field Safety Notice in June 2016

Manufacturer contacts

Hangzhou Biotest Biotech Co. Ltd
No. 17 Futai Road
Zhongtai Street
Yuhang District Hangzhou 311121
China

Telephone: +86 571 8863 0078

Email:tom.chen@biotests.com.cn

Enquiries to the authorised representative should be addressed to:

Shanghai International Holding Corp.
GmbH (Europe)
Eiffestrasse 80, Hamburg 20537
Germany

Telephone: +49 21 65951371

Email:chengqiming57@163.com

UK distributors:

SureScreen Diagnostics Ltd
1 Prime Parkway Prime Enterprise Park
Derby DE1 3QB

Telephone: 01332 365 318

Email: stephen.middleton@surescreen.com

Fullcare Holding
39-41 Chase Side
London
N14 5BP

Email:info.fhl@foxmail.com

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

  • A&E departments
  • Biomedical science departments
  • Clinical pathologists
  • Infection control departments
  • Medical directors
  • NHS walk-in centres
  • 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 practitioners
  • General practice managers
  • General practice nurses

Independent distribution

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

  • Hospitals in the independent sector
  • 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/2016/010 or 2016/006/020/291/004.

Technical Aspects

Mojisola Ajeneye,
Devices Division,
MHRA
Tel: 020 3080 7271

Email: mojisola.ajeneye@mhra.gsi.gov.uk

Clinical aspects

Dr Neil McGuire
Clinical Director,
Devices Division,
MHRA
Tel: 020 3080 6800

Email: neil.mcguire@mhra.gsi.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 Fax: 028 9052 3900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

Reporting adverse incidents in Northern Ireland

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

Reportung 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).

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RightSign (MDA/2016/010)

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