Events

Recall of STA SYSTEM - LIATEST VWF AG ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STAGO CANADA LTD./STAGO CANADA LTEE.

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
    15576
  • Event Risk Class
    III
  • Event Initiated Date
    2013-01-25
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The reagent sta-liatest vwf when used in combination with the sta-r/sta-r evolution randomly leads to a lowered result in %. event is not systematic and has been observed mainly on qc samples.

Device

STA SYSTEM - LIATEST VWF AG ASSAY
  • Model / Serial
    Model Catalog: 00518 (Lot serial: 108778); Model Catalog: 00518 (Lot serial: 109415); Model Catalog: 00518 (Lot serial: 108128); Model Catalog: 00518 (Lot serial: 108512)
  • Product Description
    Liatest VWF AG Assay
  • Manufacturer
    STAGO CANADA LTD./STAGO CANADA LTEE

Manufacturer

STAGO CANADA LTD./STAGO CANADA LTEE