Events

Recall of STA SATELLITE - NEOPLASTINE CI

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
    91555
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-31
  • 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
    Following customer complaints stago has investigated on a potential defect of homogeneity within lot and had confirmed a performance defect on a small number of vials for some lots sta - neoplastine ci plus. indeed for these lots some vials give longer clotting times than expected (decreased pt %). no complaints have been received from canadian customers.

Device

STA SATELLITE - NEOPLASTINE CI
  • Model / Serial
    Model Catalog: 00606 (Lot serial: 250246(RU)); Model Catalog: 00606 (Lot serial: 251308); Model Catalog: 00606 (Lot serial: 251730); Model Catalog: 00606 (Lot serial: 251626); Model Catalog: 00606 (Lot serial: 251772)
  • Product Description
    STA - NEOPLASTINE CI PLUS
  • Manufacturer
    STAGO CANADA LTD./STAGO CANADA LTEE

Manufacturer

STAGO CANADA LTD./STAGO CANADA LTEE