Events

Recall of BFT II Analyser(Coagulation studies analyser)

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-01174-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01174-1
  • 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
    Standard human plasma (shp, ref orkl) pre-dilution ratios given in the reference guides of the bft ii analyser do not correspond to the standard dilution procedure for endogenous coagulation factor determination. the incorrect dilution ratio stated in the reference guides is limited to the lowest calibration point.
  • Action
    Siemens are advising their customers to discontinue use of the affected application sheet for the calculation of endogenous coagulation factors from the BFT II Reference Guide Versions 3.00, 3.01 and 3.02. A revised Reference Guide will be provided. A look back at previous results is not recommended however this requirement should be determined at the discretion of the laboratory.

Device

BFT II Analyser(Coagulation studies analyser)
  • Model / Serial
    BFT II Analyser(Coagulation studies analyser)Catalogue Number: OVKF03Siemens Material Number: SMN 10458677ARTG Number: 178116 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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