Public advisory

Cord blood banked at the Canadian Cord Blood bioRepository in Edmonton, Alberta, may pose serious health risks

Last updated

Summary

Product
Cord blood currently banked at the Canadian Cord Blood bioRepository (CCBR), located in Edmonton, Alberta, that was collected, processed, tested, and/or stored anytime between March 1, 2014, and present.
Issue
Health products - Product safety
What to do

All cord blood stored at CCBR should be tested by a qualified third party before use. If you have cord blood stored at CCBR, contact them directly to understand your options.

Affected products

  • All cord blood units banked at the Canadian Cord Blood bioRepository, located in Edmonton, Alberta, that were collected, processed, tested, and/or stored between March 1, 2014, and present.

Issue

A site visit by Health Canada to the Canadian Cord Blood bioRepository (CCBR), located in Edmonton, Alberta, has identified significant issues that may pose serious health risks. The issues identified at the site could lead to the possibility of contamination and/or the transmission of infectious diseases and could negatively impact the cord blood stored.

These concerns include processing, testing, and storing cord blood in an environment that was unclean or cleaned with expired disinfectants and having inadequate measures in place to monitor temperature, humidity, and contamination in areas where cord blood is processed, tested, and stored. Health Canada also found issues related to a lack of qualified personnel; the use of uncalibrated equipment; not following established processes; and a lack of proper record-keeping.

Health Canada also identified online advertising suggesting that cord blood can be used by people other than the person the blood came from. CCBR is only permitted to store cord blood for autologous use (the donor and recipient are the same individual).

The Department informed CCBR of the concerns identified during the site visit, and that it is prohibited by law to collect, process, test, or store cord blood under unsanitary conditions. Health Canada has requested CCBR to:

  • notify customers currently storing cord blood at CCBR of the safety concerns, so they can make informed choices about using the cord blood banked there;
  • stop collecting, processing, testing, and storing new autologous cord blood under unsanitary conditions; and
  • provide a corrective action plan detailing the measures it will put in place to address the sanitary, quality control, operational, and advertising concerns.

Health Canada continues to communicate with CCBR to make sure that the compliance and safety concerns are appropriately addressed.

What you should do

  • If you want to use your stored cord blood, it should be tested prior to release by a qualified third party according to accredited standards outlined by the Canadian Standards Association for blood cells used for transplantation. This should include, at a minimum, testing for infectious disease agents and cell viability.
  • If you have cord blood stored at CCBR or if you have a contract to store cord blood with CCBR, it is recommended you contact CCBR to understand your options.
  • If you have concerns or complaints about cord blood or any health product, you can file a report with Health Canada by completing an online complaint form.
  • Health Canada has published information to help parents or caregivers make informed decisions about banking cord blood.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Biologic or vaccine
Companies
Published by
Health Canada
Audience
Identification number
RA-74512
Media and public enquiries

Media Enquiries
Health Canada
613-957-2983
media@hc-sc.gc.ca

Public Enquiries
613-957-2991
1-866-225-0709
info@hc-sc.gc.ca