Events

Recall of VITROS Chemistry Products DGXN Slides; An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ortho-Clinical Diagnostics.

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
    RC-2012-RN-00658-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00658-3
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Ortho-clinical diagnostics, inc. (ocd) recently received complaints of elevated results using heparin plasma samples for vitros chemistry products dgxn slides. as a result of their investigation into these complaints, heparin plasma is being removed as a recommended specimen type for vitros dgxn slides.
  • Action
    Laboratories are being advised to immediately discontinue using heparin plasma for VITROS DGXN Slides and to discuss previously reported results with the Laboratory Medical Director to determine appropriate course of action. Update your laboratory's Instructions for Use (IFU) Manual with the revised instructions that are provided with the recall notice.

Device

VITROS Chemistry Products DGXN Slides; An in vitro diagnostic medical device (IVD)
  • Model / Serial
    VITROS Chemistry Products DGXN Slides; An in vitro diagnostic medical device (IVD)Product Code: 8343386
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics