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
    18399
  • Event Risk Class
    III
  • Event Initiated Date
    2018-01-05
  • 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
    Siemens healthcare diagnostics has confirmed through internal investigation that the advia centaur systems cyclosporine dheas folate and ahbcm assays are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the advia centaur platforms. biotin interference has the potential to bias analytical results on these assays.

Device

ADVIA CENTAUR SYSTEM - FOLATE ASSAY
  • Model / Serial
    Model Catalog: 06367974 (Lot serial: ALL); Model Catalog: 06891541 (Lot serial: ALL); Model Catalog: 00504619 (Lot serial: ALL); Model Catalog: 06489701 (Lot serial: ALL); Model Catalog: 04564446 (Lot serial: ALL)
  • Product Description
    ADVIA CENTAUR CP SYSTEM- FOLATE ASSAY;ADVIA CENTAUR SYSTEM- HBC IGM (AHBCM) ASSAY;ADVIA CENTAUR CP SYSTEM- HBC IGM (AHBCM) ASSAY;ADVIA CENTAUR CP SYSTEM- DHEA-SO4 (DHEAS) ASSAY;ADVIA CENTAUR CP SYSTEM- CYCLOSPORINE (CSA) ASSAY;ADVIA CENTAUR SYSTEM- DHEA-S
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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