Recall of BBLT CRYSTALT ENTERIC/NONFERMENTER ID 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
    32812
  • Event Risk Class
    II
  • Event Initiated Date
    2012-12-19
  • Event Country
  • 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 citrate (cit) and malonic acid (mlo) substrates are switched from their specified locations on the prongs of the crystal enteric lid. two customers have complained that they obtain a "no id" or "tie id" result when testing salmonella isolates. a third customer complained that the substrate reactions for cit and mlo were the opposite of what is expected for the known salmonella species they were testing.

Device

  • Model / Serial
    Model Catalog: 245000 (Lot serial: 2101435); Model Catalog: 245000 (Lot serial: 2104316)
  • Product Description
    BB Crysta Enteric/Nonfermenter ID Kit
  • Manufacturer

Manufacturer