Events

Recall of MODIFIED ALSEVER'S SOLUTION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CANADIAN BLOOD SERVICES.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65582
  • Event Risk Class
    II
  • Event Initiated Date
    2005-11-14
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The recall was initiated as a result of a customer complaint indicating that some red cells stored in the solution were showing weak microscopic spontaneous agglutination and weak false positive dat results.

Device

MODIFIED ALSEVER'S SOLUTION
  • Model / Serial
    Model Catalog: (Lot serial: ALS 09)
  • Product Description
    MODIFIED ALSERVER'S SOLUTION
  • Manufacturer
    CANADIAN BLOOD SERVICES

Manufacturer

CANADIAN BLOOD SERVICES
  • Manufacturer Address
    OTTAWA
  • Source
    HC