Events

Recall of Device Recall Centricity Laboratory Core Lab; Versions 3.3, 4.0, 4.1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare It.

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
    64789
  • Event Risk Class
    Class 2
  • Event Number
    Z-1585-2013
  • Event Initiated Date
    2012-11-20
  • Event Date Posted
    2013-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117084
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use. - Product Code JQP
  • Reason
    If environment variables micro_correct_msg_type and correct_msg_type are set to different values, in microbiology result entry when released results (final report released) are changed and the corrected result messages are edited on the free-text form, some of the originally entered panel free-text is lost. for this issue to occur the original result must be amended and the environmental variabl.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter dated November 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Software correction is available. Please contact your GE service representative to request or install this update. Please contact your GE Service Representative with any question regarding this issue. For other questions please contact GE Helpdesk. Help Desk: North America: 1-888-778-3375 Help Desk: Europe: + 44 1603 877595 Help Desk: Asia Pacific + 61 3 5327 4000

Device

Device Recall Centricity Laboratory Core Lab; Versions 3.3, 4.0, 4.1
  • Model / Serial
    Software Versions 3.3, 4.0, and 4.1
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England
  • Product Description
    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact.
  • Manufacturer
    GE Healthcare It

Manufacturer

GE Healthcare It
  • Manufacturer Address
    GE Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA