Events

Recall of TSA+5% SB/MACCONKEY AGAR BI-PLATE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PML MICROBIOLOGICALS 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
    27116
  • Event Risk Class
    III
  • Event Initiated Date
    2006-05-01
  • 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
    Gram-negative organisms do not grow on the macconkey agar side of the bi-plate.

Device

TSA+5% SB/MACCONKEY AGAR BI-PLATE
  • Model / Serial
    Model Catalog: ITEM NUMBER P4600 (Lot serial: 208274-1)
  • Product Description
    TSA+5% SB/MacConkey Agar Bi-Plate
  • Manufacturer
    PML MICROBIOLOGICALS INC.

Manufacturer

PML MICROBIOLOGICALS INC.
  • Manufacturer Address
    WILSONVILLE
  • Source
    HC