Events

Recall of BD BBL FILDES ENRICHMENT

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
    78510
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-28
  • 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
    Product is not supporting the growth of haemophilus influenzae atcc 10211and other haemophilus species. there is the possibility of a false negative result no growth haemophilus if it were present in a clinical sample. upon investigation the ph was above specification on 2 batches that fail to support growth of h. influenzae.

Device

BD BBL FILDES ENRICHMENT
  • Model / Serial
    Model Catalog: 211866 (Lot serial: 1229762); Model Catalog: 211866 (Lot serial: 1186346)
  • Product Description
    BD BBL Fildes Enrichment
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.