Events

Recall of VITEK 2 SYSTEM - VITEK 2 XL INSTRUMENT

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
    45761
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-07
  • 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
    During the card loading process the sealer card pusher assembly could inadvertently make contact and move a cassette up to three card slots when the vacuum chamber is lowered which then causes the cassette to be out of alignment with the carousel incubator. as a result of this misalignment cards may be loaded into the carousel incubator in the wrong order resulting in mismatched results incorrect results or a delay in treatment due to the need to set up new cards.

Device

VITEK 2 SYSTEM - VITEK 2 XL INSTRUMENT
  • Model / Serial
    Model Catalog: 27227 (Lot serial: VTK2XL2129 to VTK2XL3264); Model Catalog: 27225 (Lot serial: VTK23119 to VTK23754)
  • Product Description
    VITEK 2 SYSTEM - VITEK 2 XL INSTRUMENT
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.