Human Tissue Authority

The regulator for human tissue and organs

Regulatory alert 001/2016 – field safety notices for syphilis testing products

Issued 2 November 2016

Notice for 

•    Designated Individuals (DIs) in the Human Application (HA) sector 
•    Licence contacts in the Organ Donation and Transplantation (ODT) sector 

Regarding an EU Rapid Alert on Substances of Human Origin issued by the Irish Health Products Regulatory Authority.

Scope
This alert is being issued by the Human Tissue Authority (HTA) and includes information relevant to DIs and Licence contacts of establishments which carry out the testing of donors of organs, tissues or cells for transplantation or human application. Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue
The Irish Health Products Regulatory Authority created an alert on the EU Rapid Alert on Substances of Human Origin platform on 27 October 2016. The alert highlights a number of field safety notices which may be of relevance to the HA and ODT sectors and which specifically relate to serological testing for syphilis in the context of donor screening.

The products identified in the field safety notices are as follows:

Product description

Product code

Manufacturer

Distributer

MicroTrak Syphilis TPHA PK

8H60124

Trinity Biotech PLC, Ireland

Trinity Biotech PLC, Ireland

TPHA OC 2000

72507

Trinity Biotech PLC, Ireland

Bio-Rad, France

MicroTrak Syphilis TPHA 100

8H60120

Trinity Biotech PLC, Ireland

Trinity Biotech PLC, Ireland

MicroTrak Syphilis TPHA 200

8H60121

Trinity Biotech PLC, Ireland

Trinity Biotech PLC, Ireland

MicroTrak Syphilis TPHA 500

8H60122

Trinity Biotech PLC, Ireland

Trinity Biotech PLC, Ireland

Bio-Rad TPHA 200

72501

Trinity Biotech PLC, Ireland

Bio-Rad, France

Bio-Rad TPHA 500

72502

Trinity Biotech PLC, Ireland

Bio-Rad, France

MicroTrak RPR Syphilis products

8H60070; 8H60070A; 8H60071; 8H60071A; 8H60071B;

8H52215;

8H52216; and 23805/23040

Trinity Biotech PLC, Ireland

Trinity Biotech PLC, Ireland

Bio-Rad RPR Syphilis products

72505;

72506; and

72508

Trinity Biotech PLC, Ireland

Bio-Rad, France

The field safety notices can be found here.

Action taken by the HTA
The HTA has issued this alert to ensure that all HTA-licensed establishments in the human application and ODT sectors which undertake syphilis testing are aware of the field safety notices.

Actions for establishments
Establishments using any of the products listed above should contact Trinity Biotech PLC, Ireland for further information:.

                                   

Trinity Biotech PLC
Southern Cross Road
IDA Business Park
Bray
Co. Wicklow  

Telephone: 00353-1-2769800
Fax: 00353-1-2769888

Please contact the HTA on 020 7269 1900 or email enquiries@hta.gov.uk if you would like any further advice on the above notice.

Audience: 
Last updated on: 10 May 2017