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Illegal “iCARE” self test kits. Priority 2 – Warning
Notice type:
Advisory
Date:
15/05/2014
Product name or type:
Illegal “iCARE” self test kits. Priority 2 – Warning
Reference:
SN2014(25)
Manufacturer Or Supplier:
Supplied via the following websites:
www.hivhometests.co.uk (Link no longer available)
www.testhiv.de (Link no longer available)
www.testhiv.nl
www.hiv-zelftest.nl
Target Audience:
General public
General Practitioners
STI clinics
Pharmacies
Healthcare professionals who use these devices
Supplies managers
Community clinics
Drug addiction treatment centres
Blood transfusion clinics
Practise nurses
Problem Or Issue:
The iCARE HIV 1&2, iCARE Syphilis, iCARE Gonorrhea and iCARE Chlamydia rapid screen self-test kits do not bear the CE mark, as required in Europe. They are being sold illegally. These tests for sexually transmitted infections (STIs) either have no CE mark, have no legal CE mark, or bear a fake CE mark.
Background Information Or Related Documents:
Illegal “iCARE” self test kits. Priority 2 – Warning Document
As these tests offer no proof that they meet the necessary legal requirements for CE marking, there is no guarantee that they work properly. Therefore someone who is infected with HIV, syphilis, gonorrhoea, or chlamydia may get a false negative test result making them think they are not infected. As a consequence, they may not get the necessary medical help and could unknowingly spread infection. On the other hand, someone who is not infected may get a false positive result telling them they are infected leading to undue stress.
Information / Related Documents:
The websites we know about that sell the illegal HIV and other STI tests are:
www.hivhometests.co.uk
www.testhiv.de
www.testhiv.nl
www.hiv-zelftest.nl
Actions To Be Taken:
The IMB advises the public:
1)
Do not buy or use
the iCARE HIV 1&2, iCARE Syphilis, iCARE Gonorrhea or iCARE Chlamydia rapid screen self-test kits sourced either on-line or from any shop / supplier.
2) Contact your GP or pharmacist if you have (or think you may have) purchased or used an iCARE self-test STI kit. If affected, consider the need to re-test.
3) Do not buy medical devices from websites that you have not verified.
The IMB advises that healthcare professionals:
1) Notify the IMB of any suspected or confirmed incidents of patients having purchased and/or used iCARE HIV 1&2, iCARE Syphilis, iCARE Gonorrhea or iCARE Chlamydia rapid screen self-test kits.
2) Advise affected patients of the need to re-test.
Further Information:
The manufacturer is thought to be:
Future Ventures Ltd
Chamber of Commerce
10a Seapower Industrial Centre
Kowloon
Hong Kong
Questions about these devices or adverse incidents should be reported to:
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6767836
E-mail:
devices@hpra.ie
Website:
www.hpra.ie
Please click here to view a PDF version of this safety notice
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Date Printed: 19/04/2024