Events

Recall of ADVIA CENTAUR XP SYSTEM - INSTRUMENT CLASS III

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
    129862
  • Event Risk Class
    III
  • Event Initiated Date
    2012-11-08
  • 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
    The wash interconnect circuit board on the advia centaur/advia centaur xp can fail due to contamination on the board during manufacturing and/or during use. when a failure occurs it is possible to have incorrect reporting of the wash1 sensors status. the fluid line of either sensor (s1 or s2) is reported to be empty when it is actually full or reported to be full when it is empty. these failures could either lead to the system not detecting an empty wash1 bottle or reservoir or stop the system from running due to a supposedly empty wash1 reservoir. if the sensors both fail in the "wet" state due to the board malfunction an erroneous but believable result may be released to the physician which is falsely high or low (depending on the assay architecture - competitive or sandwich).

Device

ADVIA CENTAUR XP SYSTEM - INSTRUMENT CLASS III
  • Model / Serial
    Model Catalog: 09066916 (Lot serial: ); Model Catalog: 078-A010-07 (Lot serial: ); Model Catalog: 04911855 (Lot serial: ); Model Catalog: 078-A001-14 (Lot serial: ); Model Catalog: 04911855 (Lot serial: >80 S/N CONTACT MANUFACTURER); Model Catalog: 078-A001-14 (Lot serial: >80 S/N CONTACT MANUFACTURER)
  • Product Description
    ADVIA CENTAUR XP SYSTEM-INSTRUMENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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