Events

Recall of Immulite 2500 ACE 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 SIEMENS.

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
    2008-04-08
  • 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-de-reactif-immulite-2500-ace-societe-siemens
  • 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 SIEMENS, on 03.04.2008, informed the users of the Immulite 2500 ACE reagent of a lot withdrawal following the discovery of an inaccuracy leading to an underestimation in the high values. The users of this device concerned by this defect in France have received the following letter (03/04/2008) (149 ko). The competent European authorities have been informed of this measure by the manufacturer. Information is addressed to laboratory managers, health facility directors and local vigilance correspondents for dissemination to the relevant biology departments.

Device

Immulite 2500 ACE reagent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    SIEMENS

Manufacturer

SIEMENS
  • Source
    LAANSM