Events

Recall of IMMULITE 1000 SYSTEM - IGF-1 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
    21620
  • Event Risk Class
    III
  • Event Initiated Date
    2017-11-30
  • 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
    In response to customer feedback siemens evaluated alternate statistical methods to determine if an alternate method would be a better fit for the reference range data published in the ifu. our investigation concluded that the lms method provided a better fit to the data and produced ranges more consistent with the expected physiological change in igf-i levels compared to use of the weighted average results reported in the ifu.

Device

IMMULITE 1000 SYSTEM - IGF-1 ASSAY
  • Model / Serial
    Model Catalog: LKIGF1 (Lot serial: N/A); Model Catalog: L2KIGF2 (Lot serial: N/A)
  • Product Description
    IMMULITE 1000 SYSTEM- IGF-1 ASSAY;IMMULITE 2000 SYSTEM- IGF-1 (INSULIN LIKE ROWTH HORMONE)ASSAY;IMMULITE SYSTEM- IGF-1 (INSULIN LIKE GROWTH HOMONE)
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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