Events

Recall of BBL LYSINE IRON AGAR

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
    17117
  • Event Risk Class
    III
  • Event Initiated Date
    2012-01-16
  • 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
    The ph is at 6.2 to 6.3 versus a specification of 6.5 to 6.9. the material contains a ph indicator (bromcresol purple) which is used as part of the mechanism of differentiation. the low ph is causing organisms that should give alkaline reactions to not give the correct reaction two complaints originating in the us (dec 2010 and june 2011) have been filed with the manufacturer in regards to failed ph results. both facilities properly prepared the medium and both found inconsistent performance based on quality control specifications. however proper qc was performed leading the facilities to not use the product.

Device

BBL LYSINE IRON AGAR
  • Model / Serial
    Model Catalog: 211363 (Lot serial: 0238264); Model Catalog: 211363 (Lot serial: 0204203); Model Catalog: 211363 (Lot serial: 0132356)
  • Product Description
    BBL Lysine Iron Agar
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.