Events

Recall of ADVIA CENTAUR CHEMILUMINESCENCE SYSTEM - ACS CENTAUR ANALYZER CLASS 2

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAYER 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
    54002
  • Event Risk Class
    II
  • Event Initiated Date
    2002-10-08
  • 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
    There is potential for an incorrect calculation of ratio test results if a ratio test is ordered through a laboratory information system (lis) and the advia centaur system is defined to calculate the result.

Device

ADVIA CENTAUR CHEMILUMINESCENCE SYSTEM - ACS CENTAUR ANALYZER CLASS 2
  • Model / Serial
    Model Catalog: 572561 (Lot serial: )
  • Product Description
    ADVIA CENTAUR ANALYZER SYSTEM
  • Manufacturer
    BAYER INC.

Manufacturer

BAYER INC.
  • Manufacturer Address
    TORONTO
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    HC