Human Tissue Authority

The regulator for human tissue and organs

Regulatory alert 001/2021 - Miltenyi CryoMACS Freezing Bag 750

Issued 17 February 2021

Notice for 

•    Designated Individuals in the Human Application sector 
 

Scope

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application to raise awareness of the potential contamination risks to cryopreserved stem cells.

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

A Field Safety Notice (FSN) has been placed on the Medicines & Healthcare products Regulatory Agency’s (MHRA) website.

The notice concerns the leaking of graft into the "pocket” in the seam of the stem cell transplant freezing bag when the graft was mixed. There was also a hole in the pocket from which the graft leaked out and which posed a risk of contamination to the graft. A “pocket” was observed in other bags of the same LOT.

 

Action taken by the HTA

The HTA has issued this alert to ensure that all HTA-licensed establishments in the human application sector which undertake cryopreservation of haematopoietic stem cells are aware of the field safety notice.

The FSN can be found hereon the MHRA's website.

The product identified in the FSN is as follows:

Miltenyi CryoMACS Freezing Bag 750, Product code 200-074-403, LOT 720070537, EXP 2023-06-29.

 

Actions for establishments

Establishments using the product listed above should contact Miltenyi Norden Biotec AB, Sweden for further information:

Miltenyi Biotec Norden AB

Medicon Village

Scheeletorget 1

223 81 Lund

Sweden

Phone: +46 46 280 7280

 Email: macs@miltenyibiotec.se

 

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: 17 Feb 2021