Events

Recall of HemosIL PT-Fibrinogen HS PLUS, 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 Werfen Australia 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-2014-RN-01292-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-12-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01292-1
  • 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
    Vials manufactured prior to june 2014 from the provided batch numbers may exhibit a yellow / brownish colour after reconstitution (yellow colour or darker) instead of the typical white to off-white colour. vials exhibiting this yellow / brownish colour were observed to cause prolonged clotting times, with several reports of controls being outside of the established ranges. if an affected vial is used with a patient sample, a significant shift in inr greater than 10% could occur with the potential to alter subsequent medical treatment.
  • Action
    Werfen is advising their customers not to use any vials identified as part of this recall, discard all boxes of potentially affected lot numbers of product. It is recommended that previously reported test results are reviewed under the supervision of the Medical Director. This acion has been closed-out on 26/08/2016.

Device

HemosIL PT-Fibrinogen HS PLUS, An in-vitro diagnostic medical device (IVD)

Manufacturer

Werfen Australia Pty Ltd