Events

Recall of ABX Diluent

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 HORIBA ABX.

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
    2005-01-18
  • 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-du-dmdiv-abx-diluent-de-la-societe-horiba-abx
  • 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 January 17, 2005, the company HORIBA ABX withdrew from the market batches 041210H1, 041217H1, 041220H1, 041223H1 of the in vitro diagnostic medical device called ABX Diluent reference 0901020 .. The company HORIBA ABX directly notified the recipients of the lots incriminated by means of the attached message (17/01/2005) (20 ko) .. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, directors of health establishments and correspondences of reactovigilance for diffusion, if necessary, to the services concerned.

Device

ABX Diluent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    HORIBA ABX

Manufacturer

HORIBA ABX
  • Source
    LAANSM