Events

Retiro De Equipo (Recall) de Device Recall VITROS Chemistry Products PHYT Slides

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
    77613
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0273-2018
  • Fecha de inicio del evento
    2017-06-12
  • Estado del evento
    Open, Classified
  • 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=156825
  • 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
    Enzyme immunoassay, diphenylhydantoin - Product Code DIP
  • Causa
    The firm identified the potential for biased results to be generated when processing vitros phyt slide product with citrate plasma specimen samples. the current instructions for use (ifu) and assay summary chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the phyt assay.
  • Acción
    Ortho-Clinical Diagnostic sent an Urgent Product Correction Letter dated June 12, 2017, sent 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 have a VITROS analyzer that can process PHYT Slides to inform them that negatively biased results may occur when processing citrate plasma samples using VITROS Chemistry Products PHYT Slides. Customers were instructed to immediately discontinue using citrate plasma samples to process VITROS PHYT Slides. They were also informed that it is still acceptable to use serum and heparin plasma samples to process VITROS PHYT Slides. Foreign affiliates were informed by e-mail on June 12, 2017 of the issue and instructed to notify their consignees of the issue and the appropriate actions to take. For further questions, please call (908) 218-8776.

Device

Device Recall VITROS Chemistry Products PHYT Slides
  • Modelo / Serial
    Unique Identifier Number ( UDI) 10758750004690; This issue affects expired, current (in date) and future product GENs.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution including Puerto Rico and the following countries: Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, Russia and Venezuela.
  • Descripción del producto
    VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. || For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 513 Technology Blvd, Rochester NY 14626-3601
  • Empresa matriz del fabricante (2017)
    The Carlyle Group LP
  • Source
    USFDA