My HPRA: Register

Diagnostic Kits for Self-Testing

Notice type: Warning

Date: 29/09/2006

  

Product name or type:
Diagnostic Kits for Self-Testing

Reference:
SN2006(07)

Manufacturer Or Supplier:
Celtic Integrated Network
www.testkitsdirect.com

Target Audience:
General Public; Pharmacists; General Practitioners; Healthcare Professionals; Laboratory Managers / Procurement Personnel; Nurses; Health Service Executive

Problem Or Issue:
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.

Background Information Or Related Documents:
Pro-active market surveillance undertaken by the Irish Medicines Board (IMB) has revealed the practice of splitting / manufacture of diagnostic kits for self-testing by Celtic Integrated Network or www.testkitsdirect.com.  This was being performed in an uncontrolled setting and involved non-CE marked devices.  The company does not have a validated quality system and has not been subject to assessment by the relevant regulatory body.

Diagnostic Kits for Self-Testing Document

Actions To Be Taken:
  • 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.

Further Information:
All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority
Medical Devices Department
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

If you have any enquiries, you may contact the Medical Devices Department at:

Telephone:  +353-1-6343429
Fax:            +353-1-6344033
Email:          medicaldevices@imb.ie
Website:      www.hpra.ie

SN2006(07): Diagnostic Kits for Self-Testing

« Back