Events

Retiro De Equipo (Recall) de Device Recall MicroScan LabPro Information Manager 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 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
    73417
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1269-2016
  • Fecha de inicio del evento
    2016-02-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-01-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144164
  • 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
    Medical device data system - Product Code OUG
  • Causa
    Beckman coulter is recalling the microscan labpro information manager system because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an id hold status.
  • Acción
    An Urgent Medical Device Recall Letter dated 2/11/2016 was sent to all customers who purchased the MicroScan LabPro Information Manager System, Version 1.0 to Version 4.41. Beckman Coulter is expanding the recall that was initiated in July 2015 regarding FA-25776 for the MicroScan LabPro Information Manager System. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Representative: http:www.beckmancoulter.com, (800) 677-7226 in US and Canada. Customers outside of US and Canada, are instructed to contact their local Beckman Coulter representative.

Device

Device Recall MicroScan LabPro Information Manager System
  • Modelo / Serial
    not applicable
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Affected geographies: Bahamas, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Morocco, Netherlands, Northern Mariana Islands, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Tunisia, Turkey, United States, Uruguay, Virgin Islands, Zimbabwe.
  • Descripción del producto
    MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 || Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. || Japan: || 10638819 LabPro v4.11 Software Update Kit || 10638820 LabPro v4.11 System Software || 10805072 LabPro MBT Non-Connect Systems v4.30 || 10805073 LabPro MBT Connect Systems v4.30 || Canada: || 6000-0008 LabPro v4.41 Panel Update-06 Kit || 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit || 10638823 LabPro v4.11 Software Update Kit || 10638825 LabPro v4.11 System Software || 10638824 LabPro v4.11 Software Update Kit || Europe: || 10638824 LabPro v4.11 Software Update Kit || 10638826 LabPro v4.11 System Software || USA: || 10714149, LabPro v4.11 Software Update Kit || 10714150 LabPro v4.11 System Software || 10975000 ASM LabPro-MBT v4.40 || 10975001 ASM LabPro-MBT v4.40 for Connect || 6000-0008 LabPro v4.41 Panel Update-06 Kit || 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit || ROW: || 6000-0008 LabPro v4.41 Panel Update-06 Kit || 10638823 LabPro v4.11 Software Update Kit || 10638825 LabPro v4.11 System Software || 10638824 LabPro v4.11 Software Update Kit || 10638826 LabPro v4.11 System Software || Product Usage: || LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes MicroScan ID and AST data, or other predefined parameters, against a series of established rules/alerts and notifies the user of unusual and/or critical conditions, which may warrant further analysis or actions.
  • 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