Events

Recall of GRAM STAIN KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON 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
    104713
  • Event Risk Class
    II
  • Event Initiated Date
    2012-04-29
  • 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
    Customers have reported an abnormally high frequency of artifacts in the gram crystal violet product (sometimes large spherical and easy to distinguish at other times smaller and more difficult to distinguish from gram positive cocci). because those artifacts may be misread as gram positive cocci a misreporting of gram stain results could occur. this misreporting could lead to initiation of incorrect patient treatment prior to the availability of a corrected gram stain or final culture result.

Device

GRAM STAIN KIT
  • Model / Serial
    Model Catalog: 212539 (Lot serial: 1348873); Model Catalog: 212525 (Lot serial: 1325324); Model Catalog: 212525 (Lot serial: 2011746)
  • Product Description
    BD Gram Stain Kit
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.