Events

Retiro De Equipo (Recall) de Device Recall QUANTALyser 240 EIA

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 Inova Diagnostics Incorporated.

¿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
    79380
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1222-2018
  • Fecha de inicio del evento
    2018-01-26
  • Estado del evento
    Terminated
  • 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=162184
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
  • Acción
    The letters were issued via email on January 26, 2018, informing the consignee of the issue and the actions to be taken. The response forms were requested to be completed and returned by February 23, 2018, indicating receipt of the notification and confirmation that the power supply has been replaced. The firm reported on February 23, 2018 that responses have been received from both consignees. For further questions, please call (858) 586-9900 x 1381.

Device

Device Recall QUANTALyser 240 EIA
  • Modelo / Serial
    Serial number 4316
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
  • Descripción del producto
    QUANTA-Lyser 240 EIA, Part #GS0241. || The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
  • Manufacturer
    Inova Diagnostics Incorporated

Manufacturer

Inova Diagnostics Incorporated
  • Dirección del fabricante
    Inova Diagnostics Incorporated, 9900 Old Grove Rd, San Diego CA 92131-1638
  • Empresa matriz del fabricante (2017)
    Werfenlife Sa.
  • Source
    USFDA