Events

Recall of VITROS 3600 and 5600 Systems using Software Version 3.2 and Below. 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-2015-RN-01098-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01098-1
  • 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
    Due to a software anomaly, the temperature in the well wash module may be out or range without notification to the operator.Temperature monitoring is performed by the vitros system for each subsystem (i.E. microslide, microtip and microwell). ortho-clinical's investigation confirmed that under very specific conditions, the temperature for the well wash module may be out of range without alerting the operator..If the anomaly occurs, it is possible for the vitros system to process samples outside of the proper temperature range, potentially leading to biased patient result. the results will not have the proper ‘wt’ (wash temperature) result code.
  • Action
    Ortho-Clinical is providing users with a guide to determine if the unit is affected by the temperature issue. If a temperature is out of range and the status bar indicates that the system is “Ready” or the temperature icon is NOT present, the user is advised to contact the sponsor’s Technical Solutions Centre. Ortho-Clinical is advising users to discuss any concerns regarding previously reported results with the Laboratory Director. This action has been closed-out on 29/08/2016.

Device

VITROS 3600 and 5600 Systems using Software Version 3.2 and Below. An in vitro diagnostic medical...
  • Model / Serial
    VITROS 3600 and 5600 Systems using Software Version 3.2 and Below. An in vitro diagnostic medical device (IVD)VITROS 3600 System Product Code: 6802783VITROS 3600 System Software Version 3.2 & BelowProduct Code: 6802866VITROS 5600 SystemProduct Code: 6802413VITROS 5600 System Software Version 3.2 & BelowProduct Code: 6802864ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics