Events

Recall of IMMUNOCAP 250 SYSTEM - SPECIFIC IGE 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
    44075
  • Event Risk Class
    III
  • Event Initiated Date
    2009-04-20
  • 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
    Phadia ab (sweden) voluntarily recalls immunocap specific ige control (art.No 10-949-01) containing vial lot bnmax bnmay or bnmaz using immunocap allergen e1. manufacturer updates information on target range values for one of seven ranges stated in the directions for use. product is a control sample used by laboratory for internal quality assurance. a new range is established for immunocap allergen e1. for some customers the results may be out of range and could result in a quality assurance investigation at the customer's site.

Device

IMMUNOCAP 250 SYSTEM - SPECIFIC IGE ASSAY
  • Model / Serial
    Model Catalog: 10-9449-01 (Lot serial: BNMAY); Model Catalog: 10-9449-01 (Lot serial: BNMAX); Model Catalog: 10-9449-01 (Lot serial: BNMAZ)
  • Product Description
    IMMUNOCAP IGE CONTROL
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.

Manufacturer

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