Events

Recall of OSMOCOLL COP(COLLOIDAL OSMOTIC PRESSURE) CONTROL REFERENCES 6 X 1ML VIALS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ELITECHGROUP INC. DBA WESCOR INC..

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
    82888
  • Event Risk Class
    III
  • Event Initiated Date
    2008-03-28
  • 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 osmocoll does not provide an accurate calibration value when used to calibrate a colloid osmometer. the reading obtained when using this osmocoll for calibration of the colloid osmometer will be elevated.

Device

OSMOCOLL COP(COLLOIDAL OSMOTIC PRESSURE) CONTROL REFERENCES 6 X 1ML VIALS
  • Model / Serial
    Model Catalog: SS-038 (Lot serial: SS-038 lot # 0397032); Model Catalog: SS-025 (Lot serial: SS-025 lot # 100299)
  • Product Description
    OSMOCOLL COP CONTROL REFERENCE SOLUTION
  • Manufacturer
    ELITECHGROUP INC. DBA WESCOR INC.

Manufacturer

ELITECHGROUP INC. DBA WESCOR INC.