Events

Recall of Microlab FAME reagent

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 ORTHO CLINICAL DIAGNOSTICS.

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
    2007-04-19
  • 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-recipients-a-reactif-microlab-fame-de-la-societe-hamilton
  • 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
    In agreement with Afssaps, the company Ortho Clinical Diagnostics informed, on 17/04/2007, the users of Microlab FAME reagent containers of the Hamilton company used on the Ortho Summit Processor, the withdrawal of several batches following a risk of leakage from the container. The users of this device concerned by this defect, in France, have received the attached mail (19/04/2007) (75 KB) This information is intended for laboratory managers, directors of health establishments and correspondents local reactive vigilance for dissemination to relevant biology departments.

Device

Microlab FAME reagent

Manufacturer

ORTHO CLINICAL DIAGNOSTICS