Events

Recall of Asserachrom Von Willebrand Factor (VWF):Collagen (CB). 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 Diagnostica Stago 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-2017-RN-00588-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00588-1
  • 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
    Following a customer complaint, stago has investigated and confirmed that asserachrom vwf:cb lot 114710(re) gives higher results compared to the other asserachrom vwf:cb tested lots for samples with a vwf:cb level above 30%. this issue is more pronounced for samples with a vwf:cb level above 50%.Based on internal testing by stago, normal samples tested are overestimated by 26% on average (relative deviation). for example: a normal plasma at 134% could be reported at 167%.The pathology samples tested and in particular the type 1 plasmas are overestimated by 38% on average (relative deviation). for example: a type 1 plasma at 56% could be reported at 75%.The quality control (qc) included in the kit does not always detect the issue.
  • Action
    Diagnostica Stago is advising users to stop using and destroy the affected lot according to current local regulations. Replacement kits will be provided.

Device

Asserachrom Von Willebrand Factor (VWF):Collagen (CB). An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Asserachrom Von Willebrand Factor (VWF):Collagen (CB). An in vitro diagnostic medical device (IVD). Reference Number: 00239Lot Number: 114710(RE)ARTG Number: 185170
  • Manufacturer
    Diagnostica Stago Pty Ltd

Manufacturer

Diagnostica Stago Pty Ltd