Events

Recall of Human anti-Fyb 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 Diamed.

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
    2005-08-01
  • 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-reactif-anti-fy-b-humain-diamed
  • 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 28 July 2005, the company DIAMED withdrew from the market the lots 19310.50.10 (per 31/07/2006), 19310.50.20 (per.31 / 07/2006) and 19310.51.10 (31/01/2007) of the in vitro diagnostic medical device called human anti-Fyb reagent reference 103901 following the demonstration of a weakening of reactivity. This device is a human test anti-FyB serum, for antiglobulin tube test .. The company has directly notified the recipients of the incriminated lots by means of the message attached (28/07/2005) (11 KB) validated by the Afssaps .. The competent European authorities concerned are informed by the Swissmedic industrialist and the competent Swiss authorities. This information is intended for laboratory managers, directors of health establishments and correspond- io-vigilance correspondents for dissemination. where appropriate, to the services concerned.

Device

Human anti-Fyb reagent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Diamed

Manufacturer

Diamed
  • Source
    LAANSM