Events

Recall of VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry Systems. 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-2013-RN-01270-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01270-1
  • 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
    While performing an on-analyser dilution, some customers have reported an increase in eae condition codes (sample metering dilution error). the data indicates that the rate of occurrence for eae codes can vary between 2 and 25% for cups within the affected arrays. when an eae condition code occurs, the processing for that sample is automatically cancelled by the system.Ortho-clinical diagnostic's investigation into the increased rate of eae condition codes determined that some of vitros mixing cup arrays may be out of specification.
  • Action
    Ortho-Clinical Diagnostics is advising their customers to continue using the Mixing Cup arrays as there is currently no alternative available. It is recommended that laboratories perform manual dilutions for samples with low volume rather than using an onboard dilution. This action has been closed-out on 10/02/2016.

Device

VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry Systems. An in vi...
  • Model / Serial
    VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry Systems. An in vitro diagnostic medical device (IVD).Product Code: 1631779ARTG Number for VITROS Chemistry Systems:180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics