Events

Recall of VITROS 3600, 4600, 5600, 5,1 FS Chemistry Systems. 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-2013-RN-01219-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01219-1
  • 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 manufacturer has received reports regarding a potential malfunction in a wire connector used in the vitros systems. there have been reports of the smell of melting plastic or smoke originating from the affected systems.
  • Action
    Ortho Clinical Diagnostics is correcting the wire connector to prevent the occurance of over heating.

Device

VITROS 3600, 4600, 5600, 5,1 FS Chemistry Systems. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    VITROS 3600, 4600, 5600, 5,1 FS Chemistry Systems. An in vitro diagnostic medical device (IVD)VITROS 3600 Immunodiagnostic Systems (Product Code 6802783)VITROS 4600 Chemistry Systems (Product Code 6802445)VITROS 5600 Integrated Systems (Product Code 6802413)VITROS 5,1 FS Chemistry Systems (Product Code 6801375, 6801890)
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics