Events

Recall of DIMENSION CHEMISTRY SYSTEM - TACR FLEX REAGENT

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
    101988
  • Event Risk Class
    II
  • Event Initiated Date
    2013-07-03
  • 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 are confirmed customer complaints of low patient sample recovery with dimension tacr flex reagent cartridge lot bb4087 and its linked calibrator lot 3bd029. quality control (qc) materials have not exhibited recovery outside of the expected range. internal complaint testing versus our reference lc/ms method confirmed an average bias of -1.6 ng/ml [-2.1 nmol/l] across the assay range. individual patients particularly samples with lower tacr values (< 5 ng/ml [6.5 nmol/l]) may show more bias due to the typical precision of each methodology.

Device

DIMENSION CHEMISTRY SYSTEM - TACR FLEX REAGENT
  • Model / Serial
    Model Catalog: DF107 (Lot serial: DF107: LOT BB4087); Model Catalog: DC107 (Lot serial: ); Model Catalog: DF107 (Lot serial: ); Model Catalog: DF107 (Lot serial: FOR ALL); Model Catalog: DC107 (Lot serial: FOR ALL); Model Catalog: DF107 (Lot serial: DC107: LOT 3BD029); Model Catalog: DC107 (Lot serial: DC107: LOT 3BD029); Model Catalog: DC107 (Lot serial: DF107: LOT BB4087)
  • Product Description
    DIMENSION CHEMISTRY SYSTEM-TACR FLEX REAGENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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