Events

Recall of DIMENSION VISTA SYSTEM - CALCIUM 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
    107153
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-11
  • 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
    Manufacturer has confirmed that dimension vista calcium (ca) flex reagent cartridge lot 16060bb may produce erroneously low results from specific well sets. this issue occurs infrequently affecting less than 1 per 350 wells (< 0.3%). if calibration is performed using an unaffected well set and samples are subsequently run using an affected well set ca results may be falsely depressed up to -2.9 mg/dl [-0.72 mmol/l]. if qc is run using an affected well set qc may detect the issue.

Device

DIMENSION VISTA SYSTEM - CALCIUM ASSAY
  • Model / Serial
    Model Catalog: K1023 (Lot serial: 16060BB)
  • Product Description
    DIMENSION VISTA SYSTEM - CALCIUM ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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