Events

Recall of VITROS Signal 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
    2006-04-05
  • 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-reactif-signal-vitros-ortho-clinical-diagnostics-france
  • 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 April 3, 2006, Ortho-Clinical Diagnostics France withdrew from the market lot 8350 (05/06/2006 expiry) of the in vitro diagnostic medical device called Signal Reagent VITROS reference CAT 107 2693 following the receipt of claims relating to biases observed on the results when using this lot of reagent. This device is used to generate the luminescence signal in all Immunoassay tests on VITROS ECi / ECiQ systems. In addition, the company informs all users of VITROS ECi / ECiQ systems of the need to follow a reinforced quality control procedure for each pack of all lots of VITROS Signal Reagent used, by means of the enclosed message (03/04 / 2006) (275 KB) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned. Alert of 17 July 2006 - update

Device

VITROS Signal Reagent

Manufacturer

Ortho-Clinical Diagnostics