Events

Retiro De Equipo (Recall) de Device Recall PrepStain GN 480 Disposable Kit

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
    61737
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1815-2012
  • Fecha de inicio del evento
    2012-03-22
  • Fecha de publicación del evento
    2012-06-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108863
  • 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
    The prepstain syringing pipettes may not dispense the minimum volume of 7.5 ml of the sample due to leaking. this event resulted in an increase in complaints of leaking syringing pipettes.
  • Acción
    BD Diagnostics sent a "BD PrepMate Syringing Pipette" letter dated March 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm encouraged customers to refer to the Operator's Manual and inspect the centrifuge tubes to verify that the correct amount of sample has been transferred. Customers experiencing this issue were instructed to discard the pipettes and contact BD Diagnostic Technical Support for a replacement. Contact the firm at 1-877-822-7771 for questions regarding this notice.

Device

Device Recall PrepStain GN 480 Disposable Kit
  • Modelo / Serial
    This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the actual product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240), which are: 100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n,  101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c,  101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b,  110128i, 110203i, 110210r
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    PrepStain GN 480 Disposable Kit Catalog/Model 490542 || This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
  • 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