Events

Recall of AUTO-DIMER

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
    74842
  • Event Risk Class
    II
  • Event Initiated Date
    2008-02-22
  • 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 d-dimer high control (part number: 1468 lot r194025) does not consistently recover within the assigned range when used with the mda auto dimer (t3103). lot r194025 is re-assigned to correct the problem.

Device

AUTO-DIMER
  • Model / Serial
    Model Catalog: 1468 (Lot serial: R194025)
  • Product Description
    Trinity Biotech D-Dimer High Control
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.

Manufacturer

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