Events

Recall of HercepTest Autostainer

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 DakoCytomation.

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
    2005-10-13
  • 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-herceptest-autostainer-dakocytomation
  • 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 October 11, 2005, DakoCytomation withdrew from the market batches 00016965 and 00018107 of the in vitro diagnostic medical device called HercepTest Autostainer reference K5207 following the posibility of obtaining falsely reduced marking intensity. This device is used to the semi-quantitative immunocytochemical assay that determines the overexpression of the HER2 protein in breast cancer tissues. This dosage is indicated in the evaluation of the patients for whom treatment with Herceptin® is envisaged. The company directly informed the recipients of the incriminated batches by means of the attached message (13/10/2005) (18 KB) validated by AFSSAPS .. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, directors of health establishments and health-vigilance correspondents for the dissemination, where appropriate, of services. concerned.

Device

HercepTest Autostainer
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DakoCytomation

Manufacturer

DakoCytomation
  • Source
    LAANSM