Events

Retiro De Equipo (Recall) de PTT-LA

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por DIAGNOSTICA STAGO.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2005-04-05
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-d-un-lot-du-dmdiv-ptt-la-diagnostica-stago
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Acción
    On April 1, 2005, DIAGNOSTICA STAGO withdrew from the market lot 041755 of the in vitro diagnostic medical device called PTT-LA reference 00599 following the possibility of elongated coagulation times with the freshly reconstituted reagent and / or shortened coagulation time with a reagent stored at 2-8 ° C. after reconstitution. This device is used for the determination of the activated partial thromboplastin time (TCA) sensitized for the detection of lupus anticoagulants (anti-phospholipid antibodies encountered in lupus) .. The company has directly notified the recipients of the offending lot by means of the message attached (01/04/2005) (107 KB) validated by Afssaps. The competent European authorities concerned are informed by Afssaps. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

PTT-LA
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    DIAGNOSTICA STAGO

Manufacturer

DIAGNOSTICA STAGO
  • Source
    LAANSM