Events

Recall of COBAS CORE Rubella IgG EIA recomb II

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 Roche 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
    2004-12-21
  • 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-cobas-core-rubella-igg-recomb-ii-de-par-roche
  • 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 December 20, 2004, Roche Diagnostics withdrew from the market batches 167822-01 and 168543-01 (expiry end of February 2005) of the in vitro diagnostic medical device called COBAS CORE Rubella IgG EIA recomb II - reference 21111264. The company Roche Diagnostics has directly notified the recipients of the incriminated lots by means of the attached message (20/12/2004) (17 KB). This information is intended for laboratory managers, directors of health establishments and correspondents of reactive vigilance. for dissemination, where appropriate, to the services concerned.

Device

COBAS CORE Rubella IgG EIA recomb II
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics