Medical Device Alert: Prostate screening home test kits manufactured by Biomerica Inc USA (MDA/2009/069)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/069 or 2009/008/024/081/014.

Technical aspects
Anna Sadio or Rosalind Polley
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3215/3119
Fax: 020 7084 3106

Email: anna.sadio@mhra.gsi.gov.uk or rosalind.polley@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 (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

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 Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922

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

Risk of false negative results which could lead to a missed diagnosis of prostate cancer.

Biomerica Inc has notified the MHRA of this recall following an in-house study which showed reduced product stability. The reduced stability of the PSA test could lead to a decrease in sensitivity and consequently a false negative result for men with elevated levels of PSA near the low end sensitivity level of the test.

The MHRA is not aware of any adverse incidents relating to this device in the UK. This device is sold over the counter and through internet suppliers to lay users. 1000 devices were shipped to the UK supplier BHR Pharmaceuticals, who has distributed the kit on to end users under the brand name Simplicity Health prostate screening test, and to the following business partners:

• Simplicity Health Ltd
• Worldwide Shopping Mall
• Self Diagnosis.

This product has also been marketed under the brand Fortel.

Biomerica Inc originally sent a Field Safety Notice to the supplier on the 17 August 2009.

Consider displaying the safety information sheet (see appendix) to alert potential users.

If a patient presents having used this test, consider the need to further advise and re-test the patient.

Advise users holding kits from the affected lot to discard it.

Actions for general practitioners:

• Consider displaying the safety information sheet (see appendix) in your surgery to alert users.
• Consider the need to re-test users.
• Advise users holding lot 1012 to discard the kit and contact their supplier.

Actions for pharmacists:

• Consider displaying the safety information sheet (see appendix) in your pharmacy to alert customers.
• Quarantine and do not sell lot 1012.
• Advise customers who have used, or are unsure if they have used, lot 1012 to contact their GP.
• Advise customers holding lot 1012 to discard the kit and contact their supplier.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• Health Protection Agency (HPA) (Directors)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (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:

• Biochemists
• Biomedical science departments
• Chief pharmacists
• Clinical governance leads
• Clinical pathologists
• Clinical pathology directors
• Health and safety managers
• Hospital at home units
• Hospital pharmacies
• Hospital pharmacists
• Medical directors
• Medical oncology, directors of
• Nursing executive directors
• Oncology nurse specialists
• Pharmacists
• Point of care testing co-ordinators
• Purchasing managers
• Radiation oncologists
• Supplies managers
• Urological surgery, directors of

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

• Adult placement
• Clinics
• Hospices
• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

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

• Community hospitals
• Community pharmacists
• Directors of public health
• General practitioners
• NHS walk-in centres
• Walk-in centres

Manufacturer
Biomerica Inc.
Ms Rachel Wagner
1533 Monrovia Avenue
Newport Beach
CA 92663
USA

Tel: +1 949 645 2111 Ext 330
Fax: +1 949 722 6674

Email: rwagner@biomerica.com

Supplier
BHR Pharmaceuticals Ltd
Mr Ramesh Patel
41 Centenary Business Centre
Hammond Close
Nuneaton
Warwickshire
CV11 6RY

Tel: 0870 034 9606
Fax: 0870 034 9607

Email: ramesh@bhr.co.uk

Safety Information Sheet

Simplicity Health Prostate Screening Test
and
Fortel Prostate Specific Antigen test

Lot number 1012

Test kits from lot number 1012 could give false negative results and should be discarded. A false negative result could delay diagnosis or treatment of prostate cancer.

If you have used a test kit from lot number 1012, or if you are not sure, please contact your GP for advice.

The test kits have been supplied by the following internet suppliers and health centres:

• Simplicity Health
• Worldwide Shopping Mall
• Self Diagnosis
• Prevent Plc
• Kent Private Clinic
• Unconfirmed others

If you require a replacement product contact BHR customer care on 0870 0349 606

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