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
    108439
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-04
  • 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
    An urgent field safety notice (ufsn) has been issued by siemens informing the customers of the biotin interference in the advia centaur tni-ultra assay. in date lots of advia centaur tni-ultra exhibit a greater than 10% change in results in samples with biotin levels up to 10 ng/ml (41 nmol/l). the instructions for use states that specimens that have up to 10 ng/ml (41 nmol/l) of biotin demonstrate =10 %change in results.

Device

ADVIA CENTAUR CP SYSTEM - TROPONIN I ULTRA (TNI-ULTRA) ASSAY
  • Model / Serial
    Model Catalog: 02789602 (Lot serial: > 20 LOTS CONTACT MFR); Model Catalog: 02790309 (Lot serial: > 20 LOTS CONTACT MFR)
  • Product Description
    ADVIA CENTAUR CP SYSTEM-TROPONIN I ULTRA (TNI-ULTRA) ASSAY;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