Events

Retiro De Equipo (Recall) de Device Recall Tosoh Automated Enzyme Immunoassay Analyzer AIA900

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 Tosoh Bioscience Inc.

¿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
    78776
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0491-2018
  • Fecha de inicio del evento
    2017-06-11
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160396
  • 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
    Fluorometer, for clinical use - Product Code KHO
  • Causa
    This recall has been initiated due to a potential malfunction of the photo interrupter (pl). the potential malfunction has been attributed to aging and premature deterioration of the pl collector current.
  • Acción
    Customers were sent a recall notification by email on July 11, 2017 informing them that their local Field Service Engineer would contact them to make arrangements to proactively replace the affected parts. Follow up notifications will be by Federal Express with verification of delivery.

Device

Device Recall Tosoh Automated Enzyme Immunoassay Analyzer AIA900
  • Modelo / Serial
    All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - U.S. Nationwide - Latin America
  • Descripción del producto
    Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. || Product Usage: || The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.
  • Manufacturer
    Tosoh Bioscience Inc

Manufacturer

Tosoh Bioscience Inc
  • Dirección del fabricante
    Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
  • Empresa matriz del fabricante (2017)
    Tosoh Corp.
  • Source
    USFDA