Events

Recall of BD BACTEC SIRE

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 BIOSCIENCES.

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
    2000-09-11
  • 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-de-reactif-denomme-bd-bactec-s-i-r-e
  • 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
    The batches 9342298 (per 01.07.01) and 9327298 (per 01.10.01) of the reagent denominated BD BACTEC SIRE reference 442102, of the company BECTON DICKINSON BIOSCIENCES are withdrawn from the market following a mislabeling. A new test is recommended for samples that have been found either resistant to streptomycin and isoniazid, or sensitive to streptomycin and isoniazid.

Device

BD BACTEC SIRE

Manufacturer

BECTON DICKINSON BIOSCIENCES
  • Source
    LAANSM