Human Tissue Authority

The regulator for human tissue and organs

Regulatory alert 001/2014 - regarding controlled rate freezers

Issued 22 April 2014

Scope

This alert is being issued by the Human Tissue Authority (HTA) and includes information relevant to Designated Individuals (DIs) of all establishments licensed for processing of tissues and cells for human application and for research. Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

The HTA has recently become aware that Planer plc has issued a field safety notice relating to certain models of the Kryo range of controlled rate freezers. Such freezers are used to gradually freeze tissues and cells in the presence of cryoprotectants, in accordance with a programmed protocol. The models identified in the field safety notice are as follows:

  • Kryo 1060-180
  • Kryo1060-380
  • Kryo3xx-1.7
  • Kryo5xx-16
  • Kryo750Plus
  • MRV Controller, and
  • Kryo-250

See attached Planer plc’s field safety notice issued by the MHRA (PDF).

Action taken by the HTA

The HTA is working with Medicines and Healthcare products Regulatory Agency (MHRA) to ensure that all HTA-licensed establishments in the human application and research sectors, which may cryopreserve cells using a controlled rate freezer, are aware of the field safety notice.

Actions for establishments

Establishments using any of the controlled rate freezer models listed above should contact Planer plc to arrange a firmware upgrade.

Ongoing advice and guidance

For more information, establishments should contact Planer plc, quoting the model reference.

Service Manager, Planer plc
110 Windmill Road
Sunbury on Thames
Middlesex, TW16 7HD, UK
Email: service@planer.com
Tel: +44 1932 755036
Quality Manager, Planer plc
110 Windmill Road
Sunbury on Thames
Middlesex, TW16 7HD, UK
Email: quality@planer.com
Tel: +44 1932 755072

Or alternatively contact the MHRA who are coordinating distribution of the field safety notice.

Mojisola Ajeneye
Medicines & Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road, London SW1W 9SZ
Tel: 020 3080 7271
Email: mojisola.ajeneye@mhra.gsi.gov.uk
MHRA ref: 2014/002/003/601/001

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.

Audience: 
Last updated on: 3 Dec 2014