Events

Recall of MISYS LABORATORY - BLOOD BANK AND BLOOD DONOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SUNQUEST INFORMATION SYSTEMS INC..

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
    23203
  • Event Risk Class
    III
  • Event Initiated Date
    2005-05-26
  • 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
    Information entered into the comment field may be lost when resulting the blood type for the first time via a blood bank instrument interface. software patch will correct the problem.

Device

MISYS LABORATORY - BLOOD BANK AND BLOOD DONOR
  • Model / Serial
    Model Catalog: (Lot serial: Sites using software ver. 6.1)
  • Product Description
    MISYS LABORATORY SYSTEM BLOOD BANK
  • Manufacturer
    SUNQUEST INFORMATION SYSTEMS INC.

Manufacturer

SUNQUEST INFORMATION SYSTEMS INC.