Events

Retiro De Equipo (Recall) de Device Recall VITROS (R) Chemistry Products Calibrator Kit 17

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
    68286
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1804-2014
  • Fecha de inicio del evento
    2014-05-12
  • Fecha de publicación del evento
    2014-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127270
  • 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
    Calibrator, secondary - Product Code JIT
  • Causa
    Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of european reference material (erm). the validation process was not complete prior to calibrator value assignment for vitros (r) chemistry products hscrp reagent (product code 6801739), generation (gen) 28.
  • Acción
    Customer Product Correction Letters (CL2014-143, dated 5/12/14) were sent on 5/12/2014 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) and /or ORTHO PLUS e-Communications to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected calibrator lot(s), and inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Distributor letter (DL2014-143) was also sent on 5/12/2014 via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and the required actions. Foreign affiliates were pre-notified via e-mail on 5/08/2014 that the communication of this issue and required actions is imminent and were sent the finalized recall communication on 5/12/2014.

Device

Device Recall VITROS (R) Chemistry Products Calibrator Kit 17
  • Modelo / Serial
    Lots 1732 (exp. 31-Jul-2014), 1743 (exp. 31-Jul-2014), 1753 (exp. 28-Feb-2015), 1764 (31-Jul-2015)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • Descripción del producto
    VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
  • Empresa matriz del fabricante (2017)
    The Carlyle Group LP
  • Source
    USFDA