Events

Recall of STAGO STA SYSTEM - LIQUID ANTI-XA 4

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
    82611
  • Event Risk Class
    III
  • Event Initiated Date
    2014-07-30
  • 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 stago hotline/call center has received some customer complaints regarding a misreading of reagent 1 (substrate)barcode on sta analyzers. diagnostica stago has investigated and confirmed that the barcode is incorrectly coded. consequently when the barcode is scanned on sta analyzers the last 3 digits displayed are "066" instead of "366". when the corresponding flyer is scanned the sta analyzer displays an error message because the lot of the vial does not match with the lot on the flyer. it is a labelling issue however the defect is only in the barcode the lot number 112366 printed on the vial is correct.

Device

STAGO STA SYSTEM - LIQUID ANTI-XA 4

Manufacturer

STAGO CANADA LTD./STAGO CANADA LTEE