Events

Recall of IMMULITE 2000 SYSTEM - ANALYZER CLASS 3

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

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
    16157
  • Event Risk Class
    III
  • Event Initiated Date
    2001-07-04
  • 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
    If a manual dilution is ordered in the "batch tests by rack screen" the software will not accurately calculate the result and the final result will not be correct.

Device

IMMULITE 2000 SYSTEM - ANALYZER CLASS 3

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC.
  • Manufacturer Address
    LOS ANGELES
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC