Events

Recall of BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic device (IVD)

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

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-00025-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00025-2
  • 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 healthcare diagnostics has observed that in very rare cases false short clotting times for pt on bcs and bcs xp with dade innovin can occur. these false short clotting times were observed with turbid, haemolytic and/or icteric samples from intensive care patients. the corresponding reaction curves of these rare samples showed a pre-peak, which can lead to falsely short clotting time. in rare cases the result was not flagged by the existing check algorithms.There is a potential to miss a prolonged prothrombin time which could lead to a delay of intervention and a risk of a significant bleed.
  • Action
    Siemens is advising users check the inference levels given in the respective Application Sheets of the BCS and BCS XP systems, as such an effect can occur in turbid, haemolytic or icteric samples from intensive care patients. Siemens will provide a software upgrade which can identify irregular reaction curves in the near future. This action has been closed-out on 27/01/2017.

Device

BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic devic...
  • Model / Serial
    BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic device (IVD)BCSSiemens Material Number (SMN):10454728, 10454729, 10454742, 10459303,10460659, 10461881 BCS XPSMN: 10459330, 10462449, 10461894, 10470625 Dade InnovinSMN: 10284500, 10445704, 10445705, 10445706, 10465673, 10465674ARTG Numbers: 178116 & 178501
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA