Events

Recall of Difco ™ BBL ™ Gram Crystal Violet Kit

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by BECTON DICKINSON.

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
  • Date
    2004-10-13
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-du-dmdiv-difco-bbl-gram-crystal-violet-de-par-becton-dickinson
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    On October 12, 2004, Becton Dickinson withdrew batches 4226886 and 4226882 (P / N 28.05.05) from the in vitro diagnostic medical device called Difco ™ BBL ™ Gram Crystal Violet Kit - references 212525 and 212526 respectively, continued the detection of a possible lack of development of the appropriate coloration characteristic of gram-positive organisms. The company Becton Dickinson directly informed the recipients of the incriminated lots by means of the attached message (12/10/2004) ( 19 ko The competent authorities have been notified directly by the industrialist.This information is addressed to the directors and correspondents of réactovigilance for diffusion, if necessary, to the services concerned.

Device

Difco ™ BBL ™ Gram Crystal Violet Kit
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON