Medical Device Alert: Pregnancy test for professional use - Clearview hCG Combo manufactured by Unipath Limited (MDA/2010/016)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/016 or 2009/011/019/081/018.

Technical aspects
Miss Susan Mclellan or Mr Guido Fumagalli
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3215/3144
Fax: 020 7084 3106

Email: susan.mclellan@mhra.gsi.gov.uk or guido.fumagalli@mhra.gsi.gov.uk

Clinical aspects
Dr Christopher Brittain
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3126
Fax: 020 7084 3111

Email: christopher.brittain@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 Central Alerting System 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

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

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 (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

False positive results may be observed when the test results are interpreted after:

• 3 minutes for urine samples
• 5 minutes for serum samples.

Specific product lot numbers contain instructions for use that have since been updated.

Since issuing MDA/2009/054 for Clearview hCG, the manufacturer has updated the instructions for use for Clearview hCG Combo and is recalling all lots containing instructions for use issued prior to the change in read time. The instructions for use have been changed from a read time of 3–10 minutes, to 3 minutes only for urine, and from 5–10 minutes, to 5 minutes only for serum. This was communicated by a Field Safety Notice issued in November 2009. Reading results before or after the read time may lead to false positive results in samples with a low level of hCG.

The MHRA has not received any complaints regarding reading times in this device and the changes in read time were as a result of internal manufacturer investigations.

The MHRA has published a guidance leaflet ‘Pregnancy Testing Top Tips’, which covers issues such as training and the importance of ensuring that devices are read at the correct time.

• Destroy, or return to the manufacturer, devices from affected lot numbers.
• Ensure that all users read results at 3 minutes for urine samples and 5 minutes for serum samples, and are aware of revised instructions for new products.
• Use a timer, stopwatch or clock as recommended in the instructions. Tests read before or after the read time should be repeated.
• Ensure standard operating procedures (SOP) are updated to reflect manufacturer’s revised instructions.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• Primary care trusts in England (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

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

• A&E departments
• A&E nurses
• Adult intensive care units
• All wards
• All clinical departments
• All Outpatient departments
• Biochemistry laboratories
• Biomedical science departments
• Chemotherapy nurses/consultants
• Chief pharmacists
• Clinical governance leads
• Clinical pathologists
• Day surgery units
• Early pregnancy units
• Family planning clinic
• General surgery
• Health and safety managers
• Hospital pharmacies
• Hospital pharmacists
• Medical directors
• Medical oncologists
• Midwifery departments
• Midwifery staff
• Nursing executive directors
• Obstetrics and gynaecology departments
• Oncology nurse specialists
• Outpatient clinics
• Pharmacists
• Point of care testing co-ordinators
• Radiation and medical oncology departments
• Radiation oncologists
• Radiation oncology, directors of
• Radiologists
• Radiology departments
• Radiology directors
• Risk managers
• Supplies managers
• Theatre managers
• Theatre nurses

Care Quality Commission (CQC) (England only) to:
The MHRA considers this to be relevant to:

• Hospitals in the independent sector
• Independent treatment centres
• Independent family planning centres
• Walk-in centres

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

• Community hospitals
• Community midwives
• Community nurses
• Community pharmacists
• District nurses
• Family planning clinics
• Minor injury units
• NHS walk-in centres
• Practice managers
• Practice nurses
• School nurses

Manufacturer
Mrs Lesley Paice
Unipath Limited
Priory Business Park
Bedford
MK44 3UP

Tel: 01234 835 530
Fax: 01234 835 003

Email: lesley.paice@invmed.com

Distributor
Mrs Lynne Smith
Inverness Medical UK
Bio-Stat House
Pepper Road
Hazel Grove
Stockport
SK7 5BW

Tel: 01614 196 306

Email: support@invmeduk.com