Events

Recall of VITROS Chemistry System. An in vitro diagnostic 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-2016-RN-00017-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00017-1
  • 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 clinical diagnostics, inc. (ortho) is initiating this recall action due to the need to clarify operator actions following u90-382 or 6lu condition codes generated by the vitros chemistry systems.U90-382 or 6lu condition codes are associated with wash errors that may occur when using vitros chemistry products for immuno-rate assays (i.E., vitros crbm, crp, dgxn, and phyt slides).If a u90-382 or 6lu condition code (i.E., associated with a wash error) occurs, the condition code text located on the vitros system and other user documentation indicates to dilute the sample. however, dilution may not be the appropriate action for all scenarios.For therapeutic monitoring, falsely low result due to dilution could potentially cause unnecessary drug dose increase, leading to side effects.
  • Action
    The sponsor is advising users to follow the instructions given in the customer letter as a temporary measure when results are flagged with a Wash Error (WE) code. A software upgrade will be installed on all affected systems in the near future as a permanent fix.

Device

VITROS Chemistry System. An in vitro diagnostic device (IVD)
  • Model / Serial
    VITROS Chemistry System. An in vitro diagnostic device (IVD)VITROS 250 Chemistry System - Product Codes: 8132086, 6801759VITROS 350 Chemistry System - Product Code: 6802153VITROS 5,1 FS Chemistry System - Product Codes: 6801375, 6801890VITROS 4600 Chemistry System - Product Code: 6802445VITROS 5600 Integrated System - Product Code: 6802413 ARTG Number 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics