Events

Retiro De Equipo (Recall) de PHENOPLAC RH-KELL device

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 DIAGAST.

¿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
    2003-02-11
  • 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-de-lots-de-dispositifs-phenoplac-de-la-societe-diagast
  • 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
    The company DIAGAST asks the holders of the lots. 108000 (per.02.03) to 114000 (per.11.03) of the in vitro diagnostic medical device called PHENOPLAC TOTAL - ref. 79713/79724. 108000 (per.02.03) to 111000 (per.09.03) of the PHENOPLAC RH-KELL device - ref. 79710/79725. 106000 (per.02.03) and 107000 (per.06.03) of the device PHENOPLAC STANDARD - ref.79712 / 79725. 103000 (per.07.03) of the PHENOPLAC 16 RH-KELL device - ref. 79716. not to use them any more and to destroy them as soon as you receive lots 115000 (per.12.03) of the device PHENOPLAC TOTAL - ref. 79724 and 112000 (per.12.03) of the device PHENOPLAC RH-KELL - ref.79730 .. This measurement is consecutive to a modification of the packaging of each microplate of the boxes guaranteeing the reactivity of the anti-e (RH5) antibody / MS16 clones + MS63 present in these plates and consequently, leading to the suppression of the systematic control, with another reagent, results "e" (RH5) negative; this measure avoids any confusion of use related to the coexistence of two techniques for the same reference.

Device

PHENOPLAC RH-KELL device
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    DIAGAST

Manufacturer

DIAGAST