Events

Recall of VITROS 5,1 FS Chemistry Systems using Software Version 2.8 & 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-00214-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00214-1
  • 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, inc. (ocd) has confirmed two instances where a vitros microslide cartridge was misidentified. both instances occurred when an operator accessed slide supply 1 (ss1) before the green indicator light was illuminated and subsequently proceeded to load a slide cartridge into slide supply 2. in each occurrence, the loaded cartridge in slide supply 2 was misidentified.
  • Action
    If an operator inadvertently accesses a Slide Supply load door before the green indicator light is illuminated and the system generates a TAS-70E or TAS-20E condition code the operator must open and close both Slide Supply doors (Slide Supply #1 & 2), not remove or add any cartridges, and initialise the system. This will cause the system software to scan all slots of both Slide Supplies in order to properly identify the contents. Discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. The resolution to this issue will be contained in the next version of software currently under development. This action has been closed-out on 31/05/2016.

Device

VITROS 5,1 FS Chemistry Systems using Software Version 2.8 & Below. An in vitro diagnostic medica...
  • Model / Serial
    VITROS 5,1 FS Chemistry Systems using Software Version 2.8 & Below. An in vitro diagnostic medical device (IVD). Product Codes: 6801375 & 6801890ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics