Events

Recall of VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and 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-2016-RN-00420-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-04-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00420-1
  • 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
    A vitros system software timing anomaly has been identified that could cause two different sample metering scenarios that may lead to erroneous results.Scenario 1: the vitros system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample.Scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) to be contaminated and diluted by sample a.There is the potential for false negative and false positive results which may lead to an inappropriate diagnosis and patient management leading to serious patient injury.
  • Action
    Ortho is providing users with interim instructions to follow to decrease the probability of the issues occurring, and can review the affected systems to determine if the errors have occurred. It is recommended to discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. Ortho will be providing users with a software update (software version 3.2.3) as a permanent correction. This can be automatically downloaded for systems connected to e-Connect or software kits provided for systems not connected to e-Connect. This action has been closed-out on 20/02/2017.

Device

VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 an...
  • Model / Serial
    VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below. An in vitro diagnostic medical device (IVD)VITROS 3600 Immunodiagnostics System, software version 3.2.2 and belowProduct Code: 6802783Unique Device ID: 10758750002979VITROS 5600 Integrated System, software version 3.2.2 and belowProduct Code: 6802413Unique Device ID: 10758750002740ARTG Number: 180199
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics