Events

Recall of PHADIA 250 SYSTEM - ALLERGENS 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
    81470
  • Event Risk Class
    III
  • Event Initiated Date
    2016-01-13
  • 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
    Some immunocap products can have stoppers which might get detached. loosening of stoppers can be caused by shaking of the immunocap carrier during transport or when manually handled. in this case the red plastic weight can push the stopper partially out of the carrier or even open the carrier. a stopper sticking out of the carrier can lead to problems with the phadia 250 carrier handling and can lead to an error message and error marked carrier.

Device

PHADIA 250 SYSTEM - ALLERGENS ASSAY
  • Model / Serial
    Model Catalog: MULTIPLE (Lot serial: no specific lot)
  • Product Description
    Phadia 250 ImmunoCAP Carriers
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.

Manufacturer

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