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
    15898
  • Event Risk Class
    II
  • Event Initiated Date
    2006-12-28
  • 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
    In blood order processing (bop)/blood order processing worklist (bopw) action buttons remain enabled allowing multiple actions to be invoked this may cause the system to display combined patient data such that a patient and/or unit other than the one expected may be updated.

Device

MISYS LABORATORY - BLOOD BANK AND BLOOD DONOR
  • Model / Serial
    Model Catalog: (Lot serial: Version 6.2); Model Catalog: (Lot serial: Version 6.1)
  • Product Description
    Misys Laboratory Blood Bank
  • Manufacturer
    SUNQUEST INFORMATION SYSTEMS INC.

Manufacturer

SUNQUEST INFORMATION SYSTEMS INC.