Events

Retiro De Equipo (Recall) de Device Recall VITROS Immunodiagnostic Products AFP Reagent Pack

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
    74346
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2145-2016
  • Fecha de inicio del evento
    2016-05-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147248
  • 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
    Kit, test,alpha-fetoprotein for testicular cancer - Product Code LOJ
  • Causa
    Ortho clinical diagnostics (ocd) confirmed that specific lots of vitros immunodiagnostic products afp reagent pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.
  • Acción
    The firm, Ortho Clinical Diagnostics, sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Customer Letter (Ref. CL2016-098) dated 5/9/2016, 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 the affected product. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue distributing and discard the affected lots; complete and return the Confirmation of Receipt form by May 18, 2016 via Fax to 1.888.557.3759 or 1.585.453.4110 or scan to PDF and email to: ConfirmationAdmin@its.jnj.com, and forward this notification if you have distributed these systems outside of your facility. If you have any questions, contact Customer Technical Services at 1-800-421-3311.

Device

Device Recall VITROS Immunodiagnostic Products AFP Reagent Pack
  • Modelo / Serial
    Lots 6471 (expiry date 19-Jul-2016), 6480 (expiry date 23-Aug-2016)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. || For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.
  • 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