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HTA issues Regulatory alert 001/2010
The HTA has issued a regulatory alert to all establishments in the human application sector.
Issue date: 2 July 2010
The HTA has today (2 July 2010) issued a regulatory alert to all human application establishments. This regulatory alert relates to a Medical Device Alert (number MDA/2010/048) which was issued on 10 June 2010 by the Medicines and Healthcare products Regulatory Agency (MHRA).
Their alert 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.
A regulatory alert is being issued by the Human Tissue Authority (HTA) in its role as Competent Authority under the European Union Tissues and Cells Directives. The Directives have now been implemented into UK law via the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
The HTA has been in contact with the MHRA and has issued this alert 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.