Events

Retiro De Equipo (Recall) de Device Recall VITROS Immunodiagnostic Products 25OH Vitamin D Total Calibrators

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
    67439
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1193-2014
  • Fecha de inicio del evento
    2014-01-15
  • Fecha de publicación del evento
    2014-03-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125454
  • 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
    Clinical Chemistry secondary Calibrator - Product Code JIT
  • Causa
    Ortho clinical diagnostics has determined that the vitros immunodiagnostic products 25-oh vitamin d total calibrators, lots 0091 through 0235, used with vitros immunodiagnostic products 25-oh vitamin d total reagent packs, may generate negatively biased results. as a result, users must immediately discontinue using all current lots of vitros 25-oh vitamin d total calibrators and reagent packs.
  • Acción
    On 1/22/2014, Customer Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees to inform them of the issue and advise them to discontinue use of the affected lot(s) and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. On 1/22/2014, Distributor Letters were sent via US Postal Service Priority Mail and/or FedEx overnight courier to US distributor consignees and instructed them to notify their consignees of the issue and actions.

Device

Device Recall VITROS Immunodiagnostic Products 25OH Vitamin D Total Calibrators
  • Modelo / Serial
    0020, 0030, 0040, 0050, 0060, 0070, 0081, 0090, 0100, 0110
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.
  • 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