Events

Recall of VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems (Software Versions 3.0 & below)

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-2014-RN-00765-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00765-1
  • 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
    Internal investigation confirmed that under specific circumstances, patient demographics may be incorrectly associated with a sample id number. this issue may occur when condition code py1-075 is generated for a sample id and the operator does not follow the instructions provided below in the condition review in v-docs.
  • Action
    End users are advised to move the sample to different cup and position if a PY1-075 condition code occurs on your VITROS® 3600, 4600 or 5600 System during sample processing. A correction will be included in the next scheduled software update. This action has been closed-out on 06/07/2016.

Device

VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Syst...
  • Model / Serial
    VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems (Software Versions 3.0 & below) VITROS 3600 Immunodiagnostic System System Product Code: 6802783 VITROS 4600 Chemistry System System Product Code: 6802445 VITROS 5600 Integrated System System Product Code: 6802413
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics