Events

Recall of DIMENSION VISTA SYSTEM - CHEM CALIBRATORS

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
    30319
  • Event Risk Class
    III
  • Event Initiated Date
    2016-03-01
  • 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
    Siemens healthcare diagnostics has received complaints of "calibrator insert missing" alerts on dimension vista chemistry 3 calibrator lot 5md004. internal investigation has confirmed that the vial barcode label reads kc130 instead of the correct catalog number kc130a. when this mismatch occurs between the vial barcode label and the instructions for use (ifu) label the "calibrator insert missing" error is triggered and displayed on the dimension vista instrument screen. there is no risk of erroneous results when this issue occurs as no results are generated.

Device

DIMENSION VISTA SYSTEM - CHEM CALIBRATORS
  • Model / Serial
    Model Catalog: KC130A (Lot serial: 5MD004)
  • Product Description
    DIMENSION VISTA SYSTEM - CHEM CALIBRATORS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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