Events

Recall of DIMENSION VISTA SYSTEM - CTNI 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
    14905
  • Event Risk Class
    III
  • Event Initiated Date
    2011-11-17
  • 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 have received customer inquiries for qc and patient shifts following calibration with lot 1dd085. internal testing has confirmed shifts with some calibrator sets from this lot. operations has tested one set of 1dd085 from six shipments from the american distribution centre (adc) in indianapolis indiana to glasgow delaware and found two sets to recover within 3% of nominal two sets to recover 3-5% below nominal and two sets to recover 5-7% below nominal. calibrator sets recovering below nominal will cause qc and patients to shift high. a patient shift of up to 26% may occur at 0.04 ng/ml which could change a sample to 0.05 ng/ml which is above the 99th percentile upper reference interval (0.045 ng/ml).

Device

DIMENSION VISTA SYSTEM - CTNI CALIBRATOR
  • Model / Serial
    Model Catalog: KC678 (Lot serial: 1DD085)
  • Product Description
    DIMENSION VISTA CARDIAC TROPONIN I CALIBRATOR (KC678) LOT 1DD085
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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