Events

Recall of VITROS 4600 Chemistry System and VITROS 5,1 FS Chemistry System. 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-01144-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-11-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01144-1
  • 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 (ortho) recently identified that under very specific conditions, the temperature in the microwell subsystem (included on other vitros systems) may potentially be out of range without the system properly alerting the operator. although the vitros 4600 system and vitros 5,1 fs system do not include a microwell subsystem, it utilises the same software as other vitros systems. ortho has estimated that there is a less than 1 in 14 million possibility that this anomaly could occur in the microslide or microtip subsystems included on chemistry systems, based on e-connectivity data.In the low likelihood that the anomaly occurs (<1 in 14 million), it is possible to process samples outside of the proper temperature range where results will not be flagged with an “it” (incubator temperature) result code. this anomaly has never been known to result in a biased result, and it is not reasonable to expect that a biased result would ever occur due to the anomaly.
  • Action
    Ortho has determined that the anomaly is due to an error in the software code. The resolution is currently under development and will be provided in a future version of software. Due to the low likelihood for this anomaly to occur, Ortho is not requiring users to monitor the temperature of their system. However, users may choose to verify that their system is within the proper temperature range. This action has been closed-out on 29/08/2016.

Device

VITROS 4600 Chemistry System and VITROS 5,1 FS Chemistry System. An in vitro diagnostic medical d...
  • Model / Serial
    VITROS 4600 Chemistry System and VITROS 5,1 FS Chemistry System. An in vitro diagnostic medical device (IVD)VITROS 4600 Chemistry System, software Version 3.2 & Below Product Code: 6802445VITROS 5,1 FS Chemistry System, software Version 2.8 & Below Product Codes: 6801375 and 6801890ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics