Diagnostic Kits for Self-Testing 에 대한 현장 안전성 서한

Field Safety Notice

SN2006(07)

2006-09-29

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/diagnostic-kits-for-self-testing&id=c994f825-9782-6eee-9b55-ff00008c97d0

Diagnostic kits for self-testing have been placed on the irish market by the above named manufacturer / supplier which do not meet requirements of medical device legislation and therefore pose a risk to public health and safety. affected hiv test kits and chlamydia test kits have been found on the irish market.  there is concern that the following affected kits may also have been placed on the irish market: syphilis, pregnancy, abo/rhesus blood typing, cholesterol and prostate specific antigen (psa) test kits. this may have resulted in supply to pharmacists by celtic integrated network or to members of the public directly via www.Testdirect.Com or internet auction sites e.G. ebay. the major issue of concern is that some of these test kits have been assembled from components of other kits that have been shown to be past their expiry date.  there is also concern over manufacture, assembly and labelling of these kits in an inappropriate manner and in an unsuitable environment.  this may result in supply to the market of test kits that do not perform as intended, and thereby pose risk to public health and safety. the possible consequences of the use of these products include, but are not limited to: inappropriate/inaccurate results leading to misdiagnosis/undetected illness, lack of appropriate medical therapy and potential for transmission to others of undetected infectious diseases.

Check to determine if you have purchased any of the above listed devices from www.testkitsdirect.com, Celtic Integrated Network or from internet auction sites If you have purchased these affected devices, check the packaging to determine if a CE mark is present, that they are not relabelled and that they are in date If you have concerns about your device do not use it and consult your doctor or pharmacist Pharmacies who have purchased devices from Celtic Integrated Networks or www.testkitsdirect.com which do not bear a valid CE mark or are over-labelled should cease supply If you have used an affected device and are concerned about your health please seek medical advice Caution is recommended if purchasing any medical device from an internet site or from a non-conventional supplier Always purchase medical devices with a CE mark and from reputable and recognised sources.