Events

Recall of ADVIA CENTAUR CP SYSTEM - TROPONIN I ULTRA (TNI-ULTRA) 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
    96347
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-21
  • 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 observed a system-to-system bias between the tni-ultrat assay on the advia centaur cp and advia centaur/advia centaur xp/advia centaur xpt systems with the advia centaur cp generating lower results than the advia centaur/advia centaur xp/advia centaur xpt system. this observation impacts customers who use the tni-ultra assay on both the advia centaur cp and advia centaur/advia centaur xp/advia centaur xpt systems interchangeably when interpreting serial testing in patient samples. this communication does not impact customers who use tni-ultra results solely from either the advia centaur/advia centaur xp/advia centaur xpt system or the advia centaur cp system.

Device

ADVIA CENTAUR CP SYSTEM - TROPONIN I ULTRA (TNI-ULTRA) ASSAY
  • Model / Serial
    Model Catalog: 02790309 (Lot serial: > 15 LOT NUMBERS CONTACT MFR); Model Catalog: 02789602 (Lot serial: > 15 LOT NUMBERS CONTACT MFR)
  • Product Description
    ADVIA CENTAUR SYSTEM-TROPONIN I ULTRA (TNI-ULTRA) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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