Events

Recall of IMMULITE 2500 SYSTEM - IGF-1 (INSULIN LIKE GROWTH HORMONE) ASSAY

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
    23120
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-07
  • 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 confirmed a negative bias in patient medians of approximately 5 to 20% using the igf-i assay as compared to the reference range medians provided in the igf-i instructions for use (ifu) with kit lots released august 2008 through july 2011.

Device

IMMULITE 2500 SYSTEM - IGF-1 (INSULIN LIKE GROWTH HORMONE) ASSAY
  • Model / Serial
    Model Catalog: L5KGF2 (Lot serial: LOTS 189-227); Model Catalog: L2KGF2 (Lot serial: LOT 441 TO 492); Model Catalog: LKGF1 (Lot serial: LOT 315 TO 335); Model Catalog: LKGF1 (Lot serial: LOT 315-335)
  • Product Description
    IMMULITE 2500 SYSTEM-IGF-1 (INSULIN LIKE GROWTH HORMONE ASSAY)
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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