Events

Recall of VIDAS SYSTEM - ANALYZER CLASS 3

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX CANADA INC..

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
    34048
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-10
  • 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
    An anomaly with the aspiration or dispensing steps performed by the pump (particularly due to pump clogging) may impact the volume of patient sample pipetted or the other solutions transferred into the strip wells. as a volume decrease could induce an impact on the biological test result the quality control vidas (qcv) test has been designed to detect pump issues and alert the user before a biological test result is affected. qcv frequency and threshold alert have been defined to enable the system to detect progressive clogging.

Device

VIDAS SYSTEM - ANALYZER CLASS 3
  • Model / Serial
    Model Catalog: W2205 (Lot serial: all); Model Catalog: 99735 (Lot serial: all); Model Catalog: REF. 410416 (Lot serial: all); Model Catalog: 410416 (Lot serial: all); Model Catalog: 99737 (Lot serial: all); Model Catalog: 99733 (Lot serial: all)
  • Product Description
    VIDAS SYSTEM - ANALYZER CLASS 3;MINIVIDAS ANALYZER
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.