Events

Retiro De Equipo (Recall) de Device Recall VITROS 4600 Chemistry 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 Ortho-Clinical Diagnostics.

¿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
    72597
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0642-2016
  • Fecha de inicio del evento
    2015-11-03
  • Fecha de publicación del evento
    2016-01-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141631
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Software anomaly may allow vitros systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. when this intermittent issue occurs, the vitros systems continue to operate and process results without notification to the user, possibly producing erroneous results.
  • Acción
    Ortho-Clinical Diagnostics sent an Urgent Product Correction Letters (Ref. CL2015-211, dated November 3, 2015) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected devices (VITROS 3600 and 5600 Systems). The notification identified the affected products, problem and actions to be taken. Foreign affiliates were informed via e-mail on 11/03/2015 of the issue and instructed to notify their consignees of the issue and required actions. Ortho-Clinical Diagnostics sent an Urgent Product Correction Letters (Ref. CL2015-221, dated November 11, 2015) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected devices (VITROS 5,1 FS and 4600 users). The notification identified the affected products, problem and actions to be taken. Foreign affiliates were informed via e-mail on 11/11/2015 of the issue and instructed to notify their consignees of the issue and required actions.

Device

Device Recall VITROS 4600 Chemistry System
  • Modelo / Serial
    Software Version 3.2 and below; Serial Numbers J46001001 -J4600636
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and Venezuela.
  • Descripción del producto
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. || Product Usage: || The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
    The Carlyle Group LP
  • Source
    USFDA