Events

Recall of DIMENSION VISTA SYSTEM - ENZYME CALIBRATOR

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
    145999
  • Event Risk Class
    II
  • Event Initiated Date
    2014-01-20
  • 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 reports of quality control (qc) shifts with pseudocholinesterase (pche) and imprecision during pche calibration with dimension vista enzyme 1 calibrator (enz 1 cal) lots 3fd034 and 3hd012. investigation by siemens confirms a loss of pche activity in the affected lots of enzyme 1 calibrator causing an elevation of qc by as much as 80% and in some instances imprecision of replicates during calibration.

Device

DIMENSION VISTA SYSTEM - ENZYME CALIBRATOR
  • Model / Serial
    Model Catalog: KC310 (Lot serial: 3HD012); Model Catalog: KC310 (Lot serial: 3FD034)
  • Product Description
    DIMENSION VISTA SYSTE-ENZYME CALIBRATOR
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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