Events

Retiro De Equipo (Recall) de eMAG System

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 bioMerieux, 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
    77989
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3119-2017
  • Fecha de inicio del evento
    2017-04-10
  • 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=158456
  • 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
    Clinical sample concentrator - Product Code JJH
  • Causa
    Some anomalies have been identified during manufacturing controls.
  • Acción
    The firm, Biomerieux, sent an "IMPORTANT: URGENT PRODUCT SAFETY CORRECTION NOTICE" letter on 4/10/2017 to its Consignees. The letter described the product, problem and actions to be taken. The Consignees were instructed to distribute this information to all appropriate personnel; retain copy for files; forward information to all parties that may use this product; perform a Main Board Re-initialization after each weekly maintenance; and complete and return the Acknowledgment Form by Fax to + 33 (0) 04 78 87 73 07 to confirm receipt of notice. A Field Service engineer will come on site to check the unit. If you require additional assistance or have any questions, please contact your local bioM¿rieux Customer Service representative or call 919-620-3396 or email: tiffiany.mentzel@biomerieux.com.

Device

eMAG System
  • Modelo / Serial
    Serial Numbers - IM03001, IM03002, IM3004, IM03005, IM03006, IM03007, IM03008, IM03009, IM03011, IM03012, IM03013, IM03014, IM03015, IM03017, IM03019
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) to states of: GA, IL, IN, MA, NC & TX and to countries of: Austria, France, Germany, Hong Kong, Italy, Netherlands, Spain, Sweden, Switzerland, Thailand and United Kingdom.
  • Descripción del producto
    eMAG System, Ref 418591 || It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment).
  • Manufacturer
    bioMerieux, Inc.

Manufacturer

bioMerieux, Inc.
  • Dirección del fabricante
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA