Events

Recall of CENTRICITY LABORATORY - CORE LAB

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS 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
    73105
  • Event Risk Class
    II
  • Event Initiated Date
    2009-05-07
  • 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
    Abnormal result flag is not being sent in the hl7 messages on results that are lower than normal range. the low abnormal results are not being flagged in the external systems expected.

Device

CENTRICITY LABORATORY - CORE LAB
  • Model / Serial
    Model Catalog: CORE (Lot serial: 27_p4); Model Catalog: CORE (Lot serial: RELEASE# 3.2.2); Model Catalog: CORE (Lot serial: PATCH ID: ultra_us_bcb_3-3-2-)
  • Product Description
    CENTRICITY LABORATORY - CORE LAB
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)