Events

Retiro De Equipo (Recall) de Device Recall ASP 6025 Vacuum Tissue Processor

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 Leica Microsystems, 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
    61535
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1473-2012
  • Fecha de inicio del evento
    2012-03-30
  • Fecha de publicación del evento
    2012-04-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108378
  • 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, tissue, automated - Product Code IEO
  • Causa
    There is a potential malfunction with the device in autorotation mode, which can lead to incorrect reagent handling of the device. the end result may lead to damage or to loss of tissue specimens.
  • Acción
    Leica Microsystems sent a Urgent Medical device Recall letter dated March 30, 2012, to all affected customers in the U.S. on the same date. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed of the potential malfunction of the device in the autorotation mode, which could lead to damage or loss of tissue specimens. The letter provided instructions on what the customer should do with the recalled product in the interim before the software fix can be installed. They were instructed to follow the steps below: 1. Remove and dispose all reagents including Paraffin and clean all bottles and Paraffin bathes. 2. Conduct a "Smart Clean" (IFU, chapter 6.1.4). 3. In Submenu "System Setup", here at "Program options", respectively "Station sequence", customer shall switch from "Concentration" to "Auto by RMS". 4. Prestored Xylene protocols shall be used instead of autorotation protocols (IFU, chapter 5.6.2 "Time - optimized Xylene infiltration programs"). Here you find the five validated programs which need to be copied to Favorite programs (IFU, chapter 5.5.3). 5. Use the Reagents, bottle set up from "Time optimized Xylene programs" (IFU, chapter 5.6.2., page 134) and implement them into submenu "Reagents" (IFU, chapter 5.2. following pages). 6. In submenu "The RMS system adjusting warning thresholds rules" (IFU, chapter 5.2.2) the validated reagent thresholds need to be implemented into Submenu "Reagents" (IFU, chapter 5.2). 7. Current Reagent management values are visible within Submenu "Reagent Status" (IFU, chapter 5.2.3) The customers were also informed that their Leica Microsystems representative will them to make the necessary arrangements to complete a software upgrade at no charge. The customers were also requested to sign and date the enclosed acknowledgement form and fax it back to Leica at 847-236-3747 or e-mail it to LMGRA@leica-microsystems.com within 10 working da

Device

Device Recall ASP 6025 Vacuum Tissue Processor
  • Modelo / Serial
    Model ASP6025, serial numbers 162, 163, 168, 169, 170, 171, 182, 183, 184, 200 through 267
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including states of: California, Florida, Georgia, Kentucky, Massachusetts, Minnesota, Mississippi, Nebraska, New York, North Carolina, the District of Columbia; and countries of: Australia, Belgium, France, Germany, China/Hong Kong, Italy, Japan, the Netherlands, Singapore, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH, Heidelberger Str. 17-19, D-69226 Nussloch, Germany; The intended use of this device is as an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Dirección del fabricante
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA