Events

Recall of Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determination of prothrombin time). 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 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
    Recall
  • Event ID
    RC-2013-RN-00151-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00151-1
  • 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
    Siemens investigations have confirmed that with sysmex cs-2000i or sysmex cs-2100i systems the last (up to 4) measurements out of a thromborel s vial may be erroneously prolonged (longer pt sec, lowered % of norm, increased inr). this may occur if the reagent in the vial is nearly used up and has been placed on board of the sysmex cs-2000i/cs-2001i systems for more than 4 hours.
  • Action
    End users are being advised to mix reagent carefully every 4 hours. Review of patient results should be carried out at the discretion of the laboratory director. Siemens representative will contact the affected customers as soon as a technical solution is available.

Device

Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determin...
  • Model / Serial
    Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determination of prothrombin time). An in vitro diagnostic medical device (IVD)Siemens Catalogue & Material Numbers: OUHP295 / 10446442 & OUHP495 / 10446445Sysmex Japan Catalogue & Material Numbers: OUHP295J / 10469932 & OUHP495J / 10469933ARTG Numbers: 178501 & 179939
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA