Events

Retiro De Equipo (Recall) de Device Recall PrepStain 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 Tripath Imaging, 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
    62117
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2088-2012
  • Fecha de inicio del evento
    2011-12-08
  • Fecha de publicación del evento
    2012-07-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109899
  • 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
    Processor, cervical cytology slide, automated - Product Code MKQ
  • Causa
    Some prep stain kit, 1.2 diti cones have been found to be leaking and the prepstain preparation kits contain incorrect preventive maintenance (pm) instructions.
  • Acción
    BD Diagnostics sent a letter dated March 2012 to all affected customers. The letter identifies the product, problem and actions that will be taken by the firm. Contact BD Diagnostics Technical Support at 1-877-822-7771, option 2 for questions regarding this letter.

Device

Device Recall PrepStain System
  • Modelo / Serial
    SAP Part numbers: 490423, 490424, 490428, 490588, 490626, 490954 and 490671.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).
  • Descripción del producto
    PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (490423); PrepStain Prep Only PM Kit, T-US (Catalog 490429); PrepStain PM Kit, T-US (Catalog 490626); PrepStain PM Kit Europe, T-US (Catalog 490428). || The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
  • Manufacturer
    Tripath Imaging, Inc.

Manufacturer

Tripath Imaging, Inc.
  • Dirección del fabricante
    Tripath Imaging, Inc., 780 Plantation Dr, Burlington NC 27215-6723
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA