Events

Recall of IMMULITE SYSTEM - IGF-1 (INSULIN LIKE GROWTH HOMONE)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    80231
  • Event Risk Class
    III
  • Event Initiated Date
    2012-10-10
  • 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
    Siemens has confirmed a negative bias against the mean values obtained with the lgcocm control lot 0026 level 2 when used with immulite/immulite 1000 igf-1 (lkgf1) kit lots 322 and above. also confirmed is an increase of mean values obtained with the lgcocm control lots 0025 025l & 0026 when used with immulite 2000/immulite 2000 xpi igf-1 (l2kgf2) kit lots 486 and 487.

Device

IMMULITE SYSTEM - IGF-1 (INSULIN LIKE GROWTH HOMONE)
  • Model / Serial
    Model Catalog: LGCOCM (Lot serial: 0025); Model Catalog: LGCOCM (Lot serial: 0026); Model Catalog: LGCOCM (Lot serial: 025L)
  • Product Description
    IMMULITE SYSTEM IGF-1 ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC