Events

Retiro De Equipo (Recall) de Device Recall CELLDYN Emerald Cleaner

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 Abbott Laboratories.

¿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
    73655
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1522-2016
  • Fecha de inicio del evento
    2016-03-24
  • Fecha de publicación del evento
    2016-04-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144669
  • 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
    Counter, differential cell - Product Code GKZ
  • Causa
    Three lots of cell-dyn emerald cleaner may have occurrences where the analyzer generates quality control out of range low for parameters rbc and plt.
  • Acción
    All customers who were shipped the affected lots were sent a Product Recall letter on March 24, 2016 via Federal Express. Letters were titled Product Recall - Immediate Action Required. An additional four lots were discovered to be affected by the recall and the firm send letters to customers affected by these lots on June 27, 2016

Device

Device Recall CELLDYN Emerald Cleaner
  • Modelo / Serial
    Lot 6853, Expiration date: 31 JUL2017; Lot 6901, Expiration date: 31JUL2017; Lot 6953, Expiration date: 30SEP2017;   May 4, 2016 - Firm advised SAN-DO that it has expanded the recall to include three additional lots:  Lot 6991, Expiration date: 30NOV2017; Lot 7024, Expiration date: 31DEC2017; Lot: 7027, Expiration date: 31DEC2017.  June 28, 2016 - firm added an additional 4 lots to recall: Lot 7044, expiration date 31JAN2018; Lot 7082, expiration date 28FEB2018; Lot 7110, expiration date 31MAR2018; Lot 7119, expiration date 30APR2018.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Austria, Bosnia & Herze, Cameroon, Egypt, Germany, Indonesia, Iraq, Lebanon, Mali, Montenegro, Netherlands, Philippines, Tanzania, Thailand, UAE, New Zealand, Malaysia, Mexico, South Korea, Jamaica, Turks & Caicos, Italy, Canada, Vietnam, Singapore, Argentina, Colombia, France, Paraguay, Australia, Uruguay, Bahrain, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Ethiopia, Finland, Greece, Switzerland, United Kingdom, Brazil, Hong, Kong, Hungary, India, Ireland, Israel, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Turkey, Jamaica, St. Martin, Nigeria, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Guatemala, Peru, and Uruguay.
  • Descripción del producto
    CELL-DYN Emerald Cleaner, product number 09H46-02. || 960mL. || IVD; || Hematology: || The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used to clean the measurement system and the fluidics.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Dirección del fabricante
    Abbott Laboratories, 4551 Great America Pkwy, Santa Clara CA 95054-1208
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA