Events

Retiro De Equipo (Recall) de Device Recall VITROS Chemistry Products Vapor Adsorption Cartridge

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
    63934
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0755-2013
  • Fecha de inicio del evento
    2012-12-13
  • Fecha de publicación del evento
    2013-01-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115070
  • 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
    Some vitros¿ chemistry products vapor adsorption cartridge cat no. 6800100 cartons incorrectly contain a particulate cartridge part no. j19612. in some instances, the particulate cartridge has been inadvertently installed on the vitros¿ system instead of the intended vitros¿ vapor adsorption cartridge which may bias results.
  • Acción
    Ortho-Clinical Diagnostics sent URGENT PRODUCT CORRECTION Letters (dated 12/13/12) along with Q&A; and Confirmation of Receipt Forms to distributors and consignees on 12/13/12. They were advised of the issue and instructed to discard their current inventory of VITROS¿ Vapor Adsorption Cartridges. On 12/13/12, foreign affiliates were informed by e-mail of the issue and instructed to notify their consignees of the issue and actions.

Device

Device Recall VITROS Chemistry Products Vapor Adsorption Cartridge
  • Modelo / Serial
    CAT No. 680 0100; the cartridges do not have lot numbers.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution, including Nationwide (USA) and the countries of AU, GM, FR, IT, SP, BR, BM, AR, CA, JA, MX, UK, CH, CL, CO, IN, EC, PE, PY, PA, PT, NZ, SG, VE and UY.
  • Descripción del producto
    Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS¿ Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS¿ 3600, VITROS¿ 5600, and VITROS¿ ECi/ECiQ Systems.
  • 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