Events

Recall of CENTRICITY LABORATORY - CORE LAB

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

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
    35137
  • Event Risk Class
    II
  • Event Initiated Date
    2008-12-12
  • 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
    Defect present in two softwares version 7.3 and version 7.4 which could incorrectly link pt.Info. to a wrong report show incorrect out-of linearity results unable to view clinically significant comments.

Device

CENTRICITY LABORATORY - CORE LAB
  • Model / Serial
    Model Catalog: CORE (Lot serial: ALL LOTS)
  • Product Description
    CENTRICITY LABORATORY - CORE LAB
  • Manufacturer
    GE HEALTHCARE

Manufacturer

GE HEALTHCARE