Retiro De Equipo (Recall) de WASP (Walk Away Specimen Process) Instrument software

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Copan Italia.

¿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
  • ID del evento
    65923
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2131-2013
  • Fecha de inicio del evento
    2013-08-09
  • Fecha de publicación del evento
    2013-08-30
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-12-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Device, microtiter diluting/dispensing - Product Code JTC
  • Causa
    The recall of the wasp (walk away specimen process) instrument was initiated because copan italia spa has upgraded the software concerning the broth inoculation table feature. the upgrade has been considered necessary from the manufacturer in order to eliminate the very low risk of rotation of the broth table when the door is open.
  • Acción
    Copan sent an Urgent WASP recall letter dated July 31, 2013, to all affected customers that received the WASP (Walk Away Specimen Process) instrument to notify them of the software upgrade concerning the broth inoculation table feature. The upgrade has been considered necessary from the manufacturer in order to eliminate the very low risk of rotation of the broth table when the door is open. This event may happen only if damage in the door locking system happens. This could result in a minor, transient injury to the user due to the impact with the rotating table. The WASP instruments involved in this upgrade are all whose serial numbers show the configuration with the broth inoculation feature activated. The machine installed in your laboratory is one of this serial number involved in the SW upgrade. The Software upgrade will be performed on site by personnel trained by Copan and no action is required by yourself. Customers will be contacted by the WASP Technical Support in order to define a date that will fit with their planning. Customers with questions are instructed to call +39 0303666130 or write to regulatory.wasp@copanitalia.com.

Device

  • Modelo / Serial
    Serial Numbers: W086-61-084/106/115/119/134/136; W086-050-179; W086-61-087/109/125/127/130/133; W086-050-144/151/153/157/170/171/181/184; W086-61-088/097/100/117; W086-050-177/178/183; W086-61-093; W086-050-143/155; W086-61-096; W086-050-164/169/159/175; W086-61-103/137/141/142; W08661-104/114118/128/138; W086050-182; W08661 111; W08661 113; W08661 124; W08661129/140; W086050150/152/154/185; W08661 139; W086050 147; W08661 110; W086050160/161/162; W086050 180; W086050 187.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Oregon and California., and the countries of France, Belgium, Italy, Denmark, Norway, Switzerland, Romania, Finland, Germany, South Africa, Canada, Ireland, UK, Sweden and Japan
  • Descripción del producto
    WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument || Catalog number: W086 || WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Copan Italia, Via Perotti, 10, Brescia Italy
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA