Events

Recall of ADVIA CENTAUR SYSTEM - FOLATE 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
    145765
  • Event Risk Class
    II
  • Event Initiated Date
    2012-11-07
  • 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 advia centaur assays listed above show changes in patient samples and quality control values when the ambient temperature of the room or laboratory shifts between 18 c - 30 c where the advia centaur system is installed. these assays are not meeting the specifications within the operating temperature range which is 18 c - 30 c. this effect occurs on either the advia centaur advia centaur xp and/or advia centaur cp systems depending on the assay and the system.

Device

ADVIA CENTAUR SYSTEM - FOLATE ASSAY
  • Model / Serial
    Model Catalog: 06891541 (Lot serial: ); Model Catalog: 02816138 (Lot serial: ); Model Catalog: 06367974 (Lot serial: ALL LOTS FOR ALL DEVICES); Model Catalog: 06891541 (Lot serial: ALL LOTS FOR ALL DEVICES); Model Catalog: 02419937 (Lot serial: ); Model Catalog: 03896216 (Lot serial: ); Model Catalog: 03204829 (Lot serial: ); Model Catalog: 01157807 (Lot serial: ); Model Catalog: 02816634 (Lot serial: ); Model Catalog: 06489701 (Lot serial: ); Model Catalog: 04612750 (Lot serial: ); Model Catalog: 03481938 (Lot serial: ); Model Catalog: 10491379 (Lot serial: ); Model Catalog: 10491244 (Lot serial: ); Model Catalog: 03009619 (Lot serial: ); Model Catalog: 08838753 (Lot serial: ); Model Catalog: 06367974 (Lot serial: ); Model Catalog: 09046419 (Lot serial: ); Model Catalog: 08861968 (Lot serial: ); Model Catalog: 10378883 (Lot serial: )
  • Product Description
    ADVIA CENTAUR FOLATE (FOL) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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