Events

Recall of VITEK MS-DS TARGET SLIDES

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
    141493
  • Event Risk Class
    III
  • Event Initiated Date
    2014-02-27
  • 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
    It has been confirmed that one of the positive qc strains enterococcus faecalis atcc 19433 was not reproducible when tested on vitek ms following culture on the trypcase soy agar + 5% sheep blood (tss) media. during development this enterococcus faecalis atcc 19433 strain was tested after culture on the colombia agar + 5% sheep blood media. therefore the culture of this strain on the trypcase soy agar + 5% sheep blood (tss) media was never validated.

Device

VITEK MS-DS TARGET SLIDES
  • Model / Serial
    Model Catalog: 410893 (Lot serial: N/A); Model Catalog: 411071 (Lot serial: N/A)
  • Product Description
    VITEK MS-DS TARGET SLIDES
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.