Events

Recall of BBL TRYPTICASE SOY AGAR W/5% SHEEP BLOOD / MACCONKEY II - I PLATE

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
    28009
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-19
  • 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
    Bd has recently confirmed a low level of surface and subsurface contamination of listeria monocytogenes on the prepared plated media. may be hazardous to health: contamination could be erroneously reported as an actual patient result causing misdiagnosis and/or mistreatment of a non-serious illness.

Device

BBL TRYPTICASE SOY AGAR W/5% SHEEP BLOOD / MACCONKEY II - I PLATE
  • Model / Serial
    Model Catalog: 221291 (Lot serial: 4143653); Model Catalog: 221263 (Lot serial: 4099228)
  • Product Description
    TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.