Human Tissue Authority

The regulator for human tissue and organs

Regulatory alert 001/2010

Issued 2 July 2010

Scope

This alert is being issued by the Human Tissue Authority (HTA) as designated Competent Authority for the purposes of the European Union Tissue and Cells Directives (2004/23/EC, 2006/17/EC and 2006/86/EC), brought into law by The Human Tissue (Quality and Safety for Human Application) Regulations 2007.

Issue

A Medical Device Alert (number MDA/2010/048) has been issued on 10 June 2010 by the Medicines and Healthcare products Regulatory Agency (MHRA).

This relates to the Hepatitis C virus total antibody kit manufactured by Abbott GmbH & Co. KG and distributed in the UK by Abbott Diagnostics. Abbott GmbH & Co. KG has advised that all lots may be affected by this issue.

A problem with this assay may lead to a false negative result which could result in a delay in the diagnosis and treatment of hepatitis C and transmission of the disease to patient contacts.

For further details please refer to information published by the MHRA.  

This alert is to ensure that all establishments using the Hepatitis C virus total antibody kit manufactured by Abbott GmbH & Co. KG are aware of the alert and the required actions.

Action taken by the HTA

The HTA has been in contact with the MHRA and has issued this alert.

Actions for establishments

URGENT

Establishments should contact laboratories carrying out donor testing to ascertain if they use or have used the kits affected by the MHRA alert.

Laboratories using this assay must follow the actions outlined in the MHRA alert.

If establishments are advised by the laboratory that the testing algorithm does not conform to the National Standard Method or have any other concerns, they should contact the HTA for further advice.

ONGOING ADVICE AND GUIDANCE

Establishments must notify the HTA of any suspected serious adverse event and / or serious adverse reaction as soon as possible after any incident;

Where a third party tests tissues and / or cells on behalf of the Licence Holder or Designated Individual the establishment shall put in place and maintain a written third party agreement;

The tests must be carried out by a qualified laboratory, licensed by the HTA for  testing  or acting under the terms of a third party agreement entered into with a licensed establishment, using EC marked testing kits where appropriate. The type of test used must be validated for the purpose in accordance with current scientific knowledge. (HTA Directions 001/2006 Annex B)

Please contact the HTA on 020 7269 1900 or email  enquiries@hta.gov.uk if you would like any further advice on any of the above points or you are storing tissue which you think may be affected.

Audience: 
Last updated on: 2 Nov 2014