Events

Retiro De Equipo (Recall) de Device Recall Cytomics FC 500 Flow Cytometry System with CXP Software, Software Version 2.2

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
    45945
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0959-2008
  • Fecha de inicio del evento
    2007-06-29
  • Fecha de publicación del evento
    2008-04-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66568
  • 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
    Automated differential cell counter - Product Code GKZ
  • Causa
    Data generation error: if the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.
  • Acción
    Consignees were notified by an Urgent Product Corrective Action letter sent on 6/29/07. The letter provided details on the data error and instruction on how to avoid the error. Users were asked to retain notification as part of the Quality Systems documentation and return a response form acknowledging receipt. For additional information, contact 1-800-526-7694.

Device

Device Recall Cytomics FC 500 Flow Cytometry System with CXP Software, Software Version 2.2
  • Modelo / Serial
    Serial Numbers: AL11058, AK20149, AJ37243, AJ08035, AK16130, AK01004, AJ33215, AK16129, AK25182, AK51355, AL13064, AJ38253, AK51353, AK07059, AL12062, AJ40271, AJ02008, AJ50371, AK07058, AL21134, AJ01002, AK12093, AL15085, AL14077, AJ30191, AJ48342, AK20152, AK07060, AJ37246, AJ06026, AK32539, AJ39259, AL04022, AJ37240, AK48336, AJ46318, AJ14074, AJ17095, AK34227, AJ47331, AJ48341, AJ33210, AK48347, AK20158, AK12095, AK16131, AK19146, AK17138, AJ25164, AJ24147, AJ51381, AJ48339, AK51359, AJ49351, AL14082, AL22140, AJ24155, AJ47332, AK51358, AL23144, AJ24151, AJ49348, AK51380, AJ38250, AK48343, AK17135, AK18141, AK09075, AK13103, AJ29184, AJ30189, AJ02006, AJ14075, AJ14073, AJ15079, AJ16087, AJ16085, AJ15078, AJ16083, AJ19103, AJ19111, AJ21116, AJ19109, AJ21114, AJ21115, AJ21117, AJ22121, AJ22122, AJ23135, AJ25165, AJ24156, AJ25159, AJ24154, AJ25167, AJ25161, AJ47327, AK07062, AK33215, AL18108, AL20125, AJ17091, AK34232, AJ25160, AJ25163, AK05025, AJ29181, AJ50366, AK48328, AJ44313, AK51370, AK34230, AJ38248, AL19111, AJ12063, AJ44309, AJ22124, AK08071, AK48334, AK25177, AJ48344, AJ42294, AK51372, AL12063, AJ24158, AJ46319, AJ43298, AK30199, AK20153, AK51354, AJ31195, AJ49349, AJ12064, AK33225, AJ35229, AK17140, AJ29183, AK16127, AJ36234, AK17134, AL09044, AJ48340, AK19147, AK39264, AL21133, AL06033, AJ19110, AJ10048, AK51361, AJ24148, AJ50368, AJ11056, AJ34221, AJ03012, AK19148, AK06051, AK34233, AK39246, AJ14072, AJ44316, AJ42292, AK48338, AK34229, AJ29182, AK18139, AK08066, AK44284, AJ05020, AK30204, AK08063, AJ34217, AJ23129, AJ23134, AJ34226, AJ37238, AK25181, AK34231, AK34228, AK34234, AK48342, AJ24142, AK39266, AJ47326, AL21135, AJ07032, AL16093, AJ38251, AJ38252, AJ43300, OAK48341, AJ23138, AJ25166, AL23145, AK39273, AJ30194, AK02009, AJ24144, AJ32209, AL13073.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- USA and country of Canada.
  • Descripción del producto
    Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number 626553, Beckman Coulter, Fullerton, CA 92834
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Dirección del fabricante
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA