Events

Recall of Elecsys 2010 assay tips

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
    2005-11-15
  • 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-du-dmdiv-elecsys-2010-assay-tips-roche-diagnostics
  • 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 November 10, 2005, the company ROCHE Diagnostics removed from the market the batch 05053110 of the in vitro diagnostic medical device called Elecsys 2010 assay tips reference 11706799 following the possibility that some tips of this lot can be plugged because of a mold of This fault leads either to an error message 58 S without result, or to values ​​that are too high or too low, all of which are respectively accompanied by alarms 51 or 50 on the Elecsys analyzer 2010. The company has directly notified the recipients of the offending lot by means of the attached message (10/11/2005) (50 KB) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. address to the laboratory managers, the directors of the health establishments and the reactovigilance correspondents for diffusion, if necessary, to the services concerned.

Device

Elecsys 2010 assay tips
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics