Events

Recall of IMMULITE 2000 SYSTEM - SHBG (SEX HORMONE BINDING GLOBULIN) 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
    17675
  • Event Risk Class
    III
  • Event Initiated Date
    2017-01-30
  • 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
    Certain lots do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8 deg.C as published in the ifu. after a two week (14 days) period may show a bias in patient samples and may result in quality control falling outside of established ranges. identified lots can exhibit an average bias of 14.5% at day 21 to 16.5% at day 28 (for shbg conc. of 5nmol?l to 170nmol/l) during the open vial adjustor stability period of 30 days. the bias observed was not conc. dependent.

Device

IMMULITE 2000 SYSTEM - SHBG (SEX HORMONE BINDING GLOBULIN) ASSAY
  • Model / Serial
    Model Catalog: L2KSH2 (Lot serial: 357 358 360 361 363)
  • Product Description
    Immulite 2000 System - SHBG
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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