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
    84703
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-20
  • 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
    Manufacturer has determined that it takes 24 minutes of incubation prior to process the samples on the immulite/immulite 1000 system for the patient sample and the pretreatment solution to reach full equilibration when using pretreatment solution (lgfa) lot 055 contained in igf-i kit lot 411. if patient samples are run before reaching full equilibration an under-recovery of up to -36% may occur. if the sample is left to incubate for more than 24 minutes prior to testing no under recovery is observed.

Device

IMMULITE 1000 SYSTEM - IGF-1 ASSAY
  • Model / Serial
    Model Catalog: LKGF1 (Lot serial: 411)
  • Product Description
    IMMULITE 1000 SYSTEM - IGF-1 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