Events

Recall of STA - Liatest vWF: Ag assay used with the STA-R/STA-R EVOLUTION analyser. An in vitro diagnostic medical device (IVD) for the measurement of von Willebrand factor.

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-2013-RN-00042-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00042-1
  • 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
    Diagnostica stago has confirmed that the sta - liatest vwf: ag assay may produce falsely low results when testing some qc and patient samples.
  • Action
    Stago are advising users to confirm all results obtained in the abnormal range (under 50%) with a manual rerun or by the creation of a dependant test at a 1:2 dilution until a corrective action has been determined. If tests are already performed in duplicate, the requirement for follow up testing should be at the discretion of the laboratory manager.

Device

STA - Liatest vWF: Ag assay used with the STA-R/STA-R EVOLUTION analyser. An in vitro diagnostic ...
  • Model / Serial
    STA - Liatest vWF: Ag assay used with the STA-R/STA-R EVOLUTION analyser. An in vitro diagnostic medical device (IVD) for the measurement of von Willebrand factor.Ref: 00518ARTG: 185170
  • Manufacturer
    Diagnostica Stago Pty Ltd

Manufacturer

Diagnostica Stago Pty Ltd