Events

Recall of ADVIA CENTAUR SYSTEM - INSTRUMENT CLASS IV

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
    149072
  • Event Risk Class
    III
  • Event Initiated Date
    2012-08-16
  • 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
    The monthly cleaning procedure (mcp) maintenance under certain circumstances may result in residual cleaning solution (bleach) in the reagent probe 1 (rp1) fluidics and the water reservoir causing false results. tests affected are total human chorionic gonadotropin (thcg) progesterone and prostate specific antigen (psa). the daily cleaning procedure (dcp) under certain circumstances may result in residual cleaning solution (bleach) in the water line causing false results that use water for test processing. test affected is toxoplasma m (toxo m).

Device

ADVIA CENTAUR SYSTEM - INSTRUMENT CLASS IV
  • Model / Serial
    Model Catalog: 078-A001-14 (Lot serial: ); Model Catalog: 04911855 (Lot serial: ); Model Catalog: 09066916 (Lot serial: ); Model Catalog: 078-A010-07 (Lot serial: ); Model Catalog: 078-A001-14 (Lot serial: N/A FOR ALL); Model Catalog: 04911855 (Lot serial: N/A FOR ALL)
  • Product Description
    ADVIA CENTAUR SYSTEM-INSTRUMENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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