Events

Recall of TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). 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-00352-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00352-1
  • 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
    The electrical cable that supplies power to the cap vibratory feeder of the recapper module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. if this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.G., serum) may splash from the tube and into another tube or onto the under carriage of the support plate. this may result in contamination of patient samples and affect patient diagnosis or treatment.
  • Action
    Ortho Clinical is advising users to check the affected systems to identify if the electrical cable has migrated out of position. A Service Representative will secure the cable in place above the support vibration feeder plate. This action has been closed-out on 09/05/2017.

Device

TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). An i...
  • Model / Serial
    TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). An in vitro diagnostic medical device (IVD)TCAutomation SystemProduct Code: 6844300Thermo Scientific Recapper Module (230V)Product Code: 952036
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics