Events

Recall of Columbia Agar ANC + 5% sheep blood

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 BIOMERIEUX.

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
    2005-11-15
  • 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-une-partie-d-un-lot-du-dmdiv-gelose-columbia-anc-5-de-sang-de-mouton-biomerieux
  • 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 10, 2005, the company bioMérieux removed from the market part of lot 798057301 (per 7/12/2005) produced between 3:43 pm and 7:38 pm of the in vitro diagnostic medical device called Columbia Agar ANC + 5% sheep blood reference 43071. This device is a selective isolation medium for the development of Gram (+) bacteria commonly found in clinical specimens. This measurement results from possible growth inhibitions due to the contamination of the part of the lot with a substance inhibiting certain strains of Staphylococcus and certain strains of Listeria. The production time appears legibly on each petri dish, with the other mentions (type of agar, number of batch, etc ..) .. The company directly warned the recipients of the incriminated batch by means of the attached message (10/11/2005) (14 ko) validated by the Afssaps. The European Competent Authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Columbia Agar ANC + 5% sheep blood
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX