Events

Recall of NICHOLS ADVANTAGE SPECIALTY SYSTEM - HUMAN GROWTH HORMONE (HGH) ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SOMAGEN DIAGNOSTICS 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
    18536
  • Event Risk Class
    II
  • Event Initiated Date
    2005-08-25
  • 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
    Internal testing showed that the nichols advantage acth cartridge lot # 62-404296 may not meet claims in the directional insert concerning correlation with the irma acth assay catalg # 40-2194.

Device

NICHOLS ADVANTAGE SPECIALTY SYSTEM - HUMAN GROWTH HORMONE (HGH) ASSAY
  • Model / Serial
    Model Catalog: (Lot serial: cat # 62-7004 lot # 62-404296)
  • Product Description
    Advantage ACTH Cartridge
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.

Manufacturer

SOMAGEN DIAGNOSTICS INC.
  • Manufacturer Address
    EDMONTON
  • Manufacturer Parent Company (2017)
    Diploma Plc
  • Source
    HC