Events

Recall of Factor IX coagulation studies on the BCS / BCS XP Automated Blood Coagulation Analyser (Actin, Actin FSL and Pathromtin SL)

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-2015-RN-00368-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00368-1
  • 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 has detected a situation with bcs / bcs xp analysers regarding factor ix assay determinations for haemophilia b patients. internal investigations showed discrepancies for siemens bcs / bcs xp within dilution studies. siemens has confirmed that samples at the lower measurement range were found elevated on the bcs/bcs xp system. patient results in the lower measuring range may be misclassified within a higher factor ix level. patients that have been evaluated for hereditary factor ix deficiency disease for the first time may have to be re-evaluated.A falsely elevated factor ix level may lead to a delay in diagnosis of a bleeding disorder related to factor ix deficiency. this may lead to additional diagnostic testing and delayed prophylactic therapy.
  • Action
    Siemens has provided a workaround for users along with a technical support contact number, whilst a permanent fix is being developed. Customers are advised to follow their laboratory protocol regarding the need for review of previously reported patient results. This action has been closed-out on 01/03/2018.

Device

Factor IX coagulation studies on the BCS / BCS XP Automated Blood Coagulation Analyser (Actin, Ac...
  • Model / Serial
    Factor IX coagulation studies on the BCS / BCS XP Automated Blood Coagulation Analyser (Actin, Actin FSL and Pathromtin SL)Siemens Material Numbers (SMN): BCS: 10454742, 10454729; BCS XP: 10461894, 10470625ARTG Number: 178116An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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