Events

Recall of Vitros Immunodiagnostic Reagent Products TSH Reagent Cartridge

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
  • Event ID
    R1801316
  • Date
    2018-01-30
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/biochimie-reactif-vitros-immunodiagnostic-products-cartouche-de-reactif-tsh-ortho-clinical-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
    ANSM has been informed of the implementation of a lot withdrawal by Ortho-Clinical Diagnostics, Inc. (Rochester). The users concerned received the attached mail (30/01/2018) (266 KB). This safety action is registered at ANSM under the number R1801316.

Device

Vitros Immunodiagnostic Reagent Products TSH Reagent Cartridge

Manufacturer

Ortho-Clinical Diagnostics