Events

Rappel de BBL GasPak Pouch System;BBL GasPak CamyPouch System

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par BD Diagnostics.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • Date
    2005-12-07
  • Pays de l'événement
    France
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-des-dmdiv-bbl-gaspak-pouch-system-bbl-gaspak-camypouch-system-bd-diagnostic
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    On December 5, 2005, BD Diagnostics removed from the market the batches listed in the attached message, in vitro diagnostic medical devices called BBL GasPak Pouch System reference 260651 and BBL GasPak CamyPouch System reference 260656. devices are pocket systems generating either an atmosphere adapted to the culture of anaerobic bacteria, or an atmosphere adapted to the culture of microaerophilic bacteria. This decision follows the detection of a bacterial contamination of the liquid reagent sachets contained in the aforementioned systems .. The company has directly notified the recipients of the offending lots by means of the message attached (05/12/2005) (69 KB) validated by Afssaps. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

BBL GasPak Pouch System;BBL GasPak CamyPouch System
  • Modèle / numéro de série
  • Description du dispositif
    in-vitro_medical_device
  • Manufacturer
    BD Diagnostics

Manufacturer

BD Diagnostics