Events

Recall of VITROS 5,1 FS System

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-2015-RN-00607-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00607-1
  • 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 has received two complaints:1) when a customer installed the add that supported the new vitros chemistry products hba1c reagent kit, the vitros 5,1 fs system posted the two condition codes ua7-239 and syd-024. the condition codes occurred because the short assay name for the new vitros assay had the same name as a user defined assay currently in use on their vitros 5,1 fs system. as a result, the user defined assay target was deleted from their system.2) when a customer installed the add, their system became unresponsive (screen freeze occurred) that required the vitros 5,1 fs system to be restarted; the system posted condition code uz0-047 after the restart was initiated.Due to a software coding error, for both scenarios, all default settings were restored from the add instead of retaining the user modified (configured) parameters and the operator was not alerted by the system.
  • Action
    OCD has determined that the root cause of this anomaly is due to an error in the software code. The resolution is currently under development and will be available in a future version of software. In the interim, OCD has provided workaround instructions to assist end users mitigate this issue. This action has been closed-out on 15/08/2016.

Device

VITROS 5,1 FS System
  • Model / Serial
    VITROS 5,1 FS SystemProduct Codes: 6801375 and 6801890Unique Device Identifier Number: 10758750001132 and 10758750001644ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics