Events

Recall of DIMENSION EXL SYSTEM - (TROPONIN) TNI 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
    98821
  • Event Risk Class
    III
  • Event Initiated Date
    2011-09-01
  • 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
    There have been customer inquiries for discordant results on qc and patients following calibration with lot 1ad045. internal testing has confirmed a 30% positive shift between the 99th percentile (0.056 ng/ml) and 0.1 ng/ml. operations has confirmed the accuracy of subsequent lots of calibrator.

Device

DIMENSION EXL SYSTEM - (TROPONIN) TNI ASSAY
  • Model / Serial
    Model Catalog: RC621 (Lot serial: 1AD045)
  • Product Description
    DIMENSION EXL SYSTEM - (TROPONIN) TNI ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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