Recall of Ferritin

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 OLYMPUS.

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
    2005-06-06
  • Event Country
  • Event Source
    ANSM
  • Event Source URL
  • 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 02 June 2005, the OLYMPUS company withdrew from the market lot 2934 (per 01/09/2005) of the in vitro diagnostic medical device called Ferritin reference OSR6150 following the detection of a microbial contamination resulting in a degradation of the analytical performance of this batch over time .. This device is used in the quantitative determination of ferritin in human serum OLYMPUS analyzer. The determination of serum ferritin is a sensitive indicator of iron stores in the body. The company has directly notified the recipients of the offending batch by means of the attached message (02/06/2005) (12 KB) validated by The relevant European Competent Authorities 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 departments concerned. .

Device

  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer

Manufacturer

  • Source
    LAANSM