Events

Retiro De Equipo (Recall) de Ortho Clinical Diagnostics VITROS Immunodiagnostic Products iPTH ReagentPack

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
    75476
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0903-2017
  • Fecha de inicio del evento
    2016-10-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150465
  • 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
    Radioimmunoassay, parathyroid hormone - Product Code CEW
  • Causa
    The device defect is a positive bias of up to 20% relative to the currently marketed roche device. in addition, the firm states that during the investigation they discovered that the cleared reference interval (ri) was not set optimally at product launch in 2010 and that the upper limit in the ifu of 53.5pg/ml is too low and should be closer to 80 pg/ml. they are in the process of submitting the data to support the revised ri in a new 510k submission and will be changing the ifu once the 510k is cleared.
  • Acción
    Ortho Clinical sent an Urgent Product Correction Notification letter dated October 5, 2016, to all affected customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received VITROS Immunodiagnostic Products iPTH to inform them of the issue and the required actions. Foreign affiliates were informed by email on October 5, 2016, of the issue and instructed to notify their customers of the issue and the required actions. Required Actions - Until further notice, be aware of positively biased results when using the device. Discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. Post the notification by your VITROS System or with your user documentation. In accordance with regulatory requirements, complete and return the Confirmation of Receipt form via email to: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM. Customers with questions can call the Ortho Care Technical Solutions Center at 1-800-421-3311. For further questions regarding this recall, please call (585) 453-3452.

Device

Ortho Clinical Diagnostics VITROS Immunodiagnostic Products iPTH ReagentPack
  • Modelo / Serial
    Lot / Expiry date: 1) 0700 (18 Oct 2016), 0710 (14 Nov 2016), 0748 (16 Feb 2017, 0758 (06 Mar 2017); 2) 0728 (12 Dec 2016), 0738 (02 Jan 2017), 0768 (10 Apr 2017)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution : and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
  • Descripción del producto
    VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators || For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Intact PTH is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS
  • Dirección del fabricante
    ORTHO-CLINICAL DIAGNOSTICS, FELINDRE MEADOWS, Bridgend United Kingdom
  • Empresa matriz del fabricante (2017)
    The Carlyle Group LP
  • Source
    USFDA