Events

Recall of BacT / Alert MP

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
    2005-06-09
  • 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-bact-alert-mp-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 June 7, 2005, the company bioMérieux withdrew the lot 1003297 (per 31/08/2005) from the in vitro diagnostic medical device called BacT / Alert MP reference 259797, because this batch is not in conformity with the requirements of the new re-control procedure, internal to the company .. This kit is designed to be used with MB / BacT or BacT / ALERT 3D PLCs for the detection and recovery of mycobacteria in sterile clinical specimens other than the blood and from clinical samples fluidized and decontaminated .. The company has directly notified the recipients of the offending lot by means of the message attached (07/06/2005) (14 KB) validated by Afssaps .. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

BacT / Alert MP
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX