Recall of Dade Innovin Reagent. An in vitro diagnostic medical device (IVD) (Prothrombin time assay)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Siemens have identified that majority of current lots of this product are affected by reduced reagent stability after reconstitution.. affected lots were identified before release during regular quality control processes and became part of an extended testing program to verify reagent stability. there has been no impact on product performance within the reduced stability.
  • Action
    Siemens is advising end users that reduced in use stability claims will be indicated on a ‘Pink Note’ included with the kits. This action has been closed-out on 31/05/2016.


  • Model / Serial
    Dade Innovin Reagent. An in vitro diagnostic medical device (IVD) (Prothrombin time assay)Affected lot numbers that have been supplied: 539267, 539267B, 539273, 539280, 539281, 539298, 539301, 539303A, 539305, 539306, 539309ARTG Number: 178501
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source