Events

Recall of VITROS Chemistry Products PHYT 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 Australia Pty Ltd.

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-2018-RN-00604-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00604-1
  • 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 has confirmed customer complaints regarding the potential for imprecise results when using impacted vitros phyt slides. the results obtained were either positively or negatively biased across the vitros phyt slides measuring range of 3.00–40.00 ug/ml (11.88–158.40 umol/l).To date, no adverse events have been reported as a result of this issue.
  • Action
    Ortho is requesting customers to immediately discontinue using and discard all remaining inventory of VITROS PHYT Slides for the affected lots. Ortho will replace remaining inventory of the affected lots or credit accounts.

Device

VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD).Unique Identifier Number:10758750004690Product Code: 8298671Generation: GEN 16Coating ID: Coating 0165Multiple Lot NumbersExpiry date:15 March 2018 through to 15 June 2018ARTG Number: 245278
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd