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
    15362
  • Event Risk Class
    II
  • Event Initiated Date
    2006-11-08
  • 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
    Under rare circumstances in blood order processing (bop) the qa algorithym failure. "specimen reaction entry does not match system interpretation" is not generated when the reaction result pattern fails to match the reaction result interpretation. this only occurs when resulting user defined test codes containing the character string "rck" (for example btrck1). the system defined percent codes are not affected by this problem.

Device

MISYS LABORATORY - BLOOD BANK AND BLOOD DONOR

Manufacturer

SUNQUEST INFORMATION SYSTEMS INC.