Events

Retiro De Equipo (Recall) de Device Recall CellDyn 4000 and CellDyn Sapphire Vent Needle head assembly

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 Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA.

¿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
    56775
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0489-2011
  • Fecha de inicio del evento
    2010-07-23
  • Fecha de publicación del evento
    2010-11-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94516
  • 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
    The vent needle, which is built into the vent head assembly on the cell-dyn sapphire instrument and which is used directly on the cell-dyn 4000 instrument, may be defective, which may result in an undetected short sample, generating incorrect low results, or which may bend, preventing aspiration of the sample.
  • Acción
    Abbott Laboratories issued a Product Recall letter dated July 23, 2010 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were instructed to discard all affected vent needles and replace them with the needle included with the recall letter. Customers may contact customer support at 1-877-422-2688 concerning this recall.

Device

Device Recall CellDyn 4000 and CellDyn Sapphire Vent Needle head assembly
  • Modelo / Serial
    Manufacturing date codes between 01.Jan.2010 and 23.Jun.2010
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: Thoroughout the US, and in the countries of Argentina, Canada, Germany, Hong Kong, Japan, and Singapore.
  • Descripción del producto
    CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers; || CELL-DYN Sapphire Vent Head Assembly, List Number: 08H53-02, || CELL-DYN Sapphire Accessory Kit, List Number: 08H03-01, || CELL-DYN 4000 Vent Needle, List Number: 02H61-01, || CELL-DYN 4000 Accessory Kit, List Number: 01H20-01, || CELL-DYN 4000 Vent Needle Upgrade Kit, List Number: 9130576, || CELL-DYN 4000 Vent Head Assembly, List Number: 8921187101, || CELL-DYN 4000 Sample Processor Assembly, List Number: 8921198201; || Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara, CA
  • Manufacturer
    Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

Manufacturer

Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
  • Dirección del fabricante
    Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • 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