Nonconforming Blood Components and Plasma Protein Products
Recall of Blood Components Manufactured by Canadian Blood Services
On occasion, circumstances require that Canadian Blood Services recall blood components or plasma protein products that have been already released and issued to a hospital. These circumstances include donors who forget at the time they completed the donor questionnaire that they visited a vacation area where malaria is known to occur , or donors who develop a viral illness post donation and subsequently contact us. Canadian Blood Services holds a blood establishment license and is required to follow Health Canada regulations regarding recalls.
When these events occur, Canadian Blood Services will issue a Notification of Component Recall/Withdrawal to your hospital (view sample document). The notification is intended for recalls involving a small number of blood components, and will include information on the reason for the recall. Complete the form to confirm receipt of the notification and indicate the final disposition of the blood component, and return it to the fax number indicated on the form.
In events that require the recall of a large number of blood components, your hospital will receive documents better suited to this situation, and may include a memo with background and instructions, and a spreadsheet listing the implicated blood components.
Please see The National Advisory Committee on Blood and Blood Products website for recipient recall recommendations.
Quarantine of Blood Components Manufactured by Canadian Blood Services
Canadian Blood Services may notify hospital customers and request they quarantine a blood component(s) that we suspect is/are nonconforming, while additional information is gathered or an investigation is completed. The quarantine is to prevent the transfusion of implicated blood components. See section 104 of CSA-Z902-10 Blood and blood components. Subsequently, Canadian Blood Services will notify hospitals that the implicated components may be released for transfusion, or we may proceed to issue a recall notification.
Quarantine or Recall of Plasma Protein Products distributed by Canadian Blood Services
The quarantine and/or recall process of a plasma protein product is initiated by the manufacturer of the implicated product. Canadian Blood Services will be notified in writing by the manufacturer, and Canadian Blood Services will then notify hospitals in writing, which will include a copy of the manufacturer’s notification. The document will include the name and lot number(s) of implicated products, and a request to acknowledge receipt.