Events

Recall of IgM immunoglobulin anti-rubella

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 DiaSorin.

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
    2003-02-14
  • 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-dispositif-medical-de-diagnostic-in-vitro-denomme-liaison-rubella-igm-reference-310730-par-la-societe-diasorin
  • 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
    DiaSorin withdraws lot 370160 (March 2003) from the market for the in vitro diagnostic medical device called Liaison Rubella IgM - reference 310730, following a problem with the stability of one of the components of this batch appearing approximately 6 months after its release. manufacturing and leading to an increase in the number of results in the gray zone or in low positive cases. This device allows IgM immunoglobulin anti-rubella to be assayed on the linkage automaton (closed system).

Device

IgM immunoglobulin anti-rubella
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DiaSorin

Manufacturer

DiaSorin