Events

Recall of PHADIA 100 SYSTEM - ELIA SMDP WELL

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
    82477
  • Event Risk Class
    II
  • Event Initiated Date
    2016-01-08
  • 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
    Analysis of patient samples received in complaint investigations showed that several samples caused unspecific signals up to 22 u/ml. the unspecific signals are neither caused by anti-sm antibodies nor by anti-streptavidin antibodies but are due to other unspecific signals with an as yet unknown cause.

Device

PHADIA 100 SYSTEM - ELIA SMDP WELL
  • Model / Serial
    Model Catalog: 14-5624-01 (Lot serial: 0018)
  • Product Description
    EliA SmDp Well
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.

Manufacturer

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