Events

Recall of BD BACTEC ™ MGIT ™ 960 SIRE 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
    2004-11-23
  • 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-d-un-lot-du-dmdiv-trousse-bd-bactec-mgit-960-sire-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 November 23, 2004, Becton Dickinson withdrew from the market lot 4154541 (per 15.10.05) of the in vitro diagnostic medical device called BD BACTEC ™ MGIT ™ 960 SIRE Kit - reference 245123, following the identification of any mushroom / mold contamination of the BD BACTEC ™ MGIT ™ 960 SIRE supplement / lot 41400062 included in the above-mentioned package. Becton Dickinson directly informed the recipients of the offending lot by means of the enclosed message ( 23/11/2004) (14 KB). The competent authorities have been notified directly by the manufacturer. This information is addressed to the directors of health establishments and correspondents of reactovigilance for diffusion, if necessary, with the services concerned .. Message Becton Dickinson (23/11/2004 ) (14 KB)

Device

BD BACTEC ™ MGIT ™ 960 SIRE Kit
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON