Events

Recall of ORTHO VISION Analyser, software version 2.12.6 & below and ORTHO VISION Max Analyser, software version 2.12.10 (for ORTHO BioVue Cassettes). 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-2016-RN-00286-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00286-1
  • 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 is issuing this notice due to an unlikely scenario in which a user inappropriately removes or interchanges samples in an onboard sample rack or removes an onboard dilution tray after making a reagents load/unload request. if an unexpected change is made in a load station location that was not selected via the graphical user interface (gui), the system will not detect the change. if users deviate from normal process for changing patient samples, these can be associated with another sample id, potentially leading to erroneous test results. in the unlikely event the error occurred, it may lead to an incorrect rh(d) or incorrect cross matching result. there have been no reports of patient injury.Update: ortho has advised an additional unlikely scenario where it is also possible for a user to unexpectedly remove or interchange diluents in a location that was not selected on the graphical user interface (gui) after making a reagents load/unload request.
  • Action
    Ortho Clinical Diagnostics is advising users to ensure samples, diluents and dilution trays are loaded and unloaded using the Graphical User Interface (GUI). The issue will be addressed in a future software version. Any concerns regarding previously generated results should be discussed with the Laboratory Director. This action has been closed-out on 02/02/2017.

Device

ORTHO VISION Analyser, software version 2.12.6 & below and ORTHO VISION Max Analyser, software ve...
  • Model / Serial
    ORTHO VISION Analyser, software version 2.12.6 & below and ORTHO VISION Max Analyser, software version 2.12.10 (for ORTHO BioVue Cassettes). An in vitro diagnostic medical device (IVD)ORTHO VISION Analyser for ORTHO BioVue Cassettes Software Versions: 2.12.6 and below Product Code: 6904579ORTHO VISION Max Analyser for ORTHO BioVue CassettesSoftware Versions: 2.12.10Product Code: 6904578ARTG Number: 229946
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics