Events

Retiro De Equipo (Recall) de Device Recall COULTER LH 750 Analyzer

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 Beckman Coulter 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
    61255
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1242-2012
  • Fecha de inicio del evento
    2011-12-01
  • Fecha de publicación del evento
    2012-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107670
  • 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 recall was initiated because beckman coulter has confirmed that the auto stop and auto transmit features for quality control become disabled after scanning assay values from coulter 5c and retic-c cell controls assay sheets using the 2d barcode scanner.
  • Acción
    Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 30, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers who use the Auto-Stop or Auto-Transmit to ensure the settings are enabled in Control Setup after scanning the assay sheets. Additionally, a Response Form was included for customers to complete and return. Contact Beckman Coulter Customer Service at (800) 526-7694 for questions regarding this notice.

Device

Device Recall COULTER LH 750 Analyzer
  • Modelo / Serial
    Not available.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the Virgin Islands and the countries of Algeria Andorra Angola Antigua and Barbuda Argentina Australia Bahrain Bangladesh Belgium Bermuda Brazil Bulgaria Burundi Cameroon Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Ethiopia France Germany Greece Guadeloupe Guam Guatemala Honduras Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Jordan Korea, Republic of Kuwait Latvia Lebanon Libyan Arab Jamahiriya Lithuania Macao Malaysia Mayotte Mexico Monaco Morocco Myanmar Namibia Netherlands New Zealand Norway Oman Pakistan Panama Philippines Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Thailand Trinidad and Tobago Tunisia Turkey United Arab Emirates United Kingdom Uruguay Venezuela Viet Nam Yemen Zimbabwe
  • Descripción del producto
    COULTER LH 750 Analyzer, || part number: LH750 System Help 2D1.103272, || PN 6605632, PN 6605632R & PN A85570. || SW Version 2D1, 2D2. || Serial Number: all. || The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automatedmethod for enumeration of RBCs and WBCs in body fluids.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA